510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

K160807510(k) TraditionalCleared Apr 6, 201613-day reviewClass II21 CFR 892.1550Recalls 33

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Philips Ultrasound, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Apr 6, 2016 as substantially equivalent to K132304 (Philips Ultrasound, Inc., 2013) after a 13-day review. Its family tree reaches back 16 generations to 1995. 6 of the 226 devices in its family, counting itself, have a Class I recall. 100 later devices descend from it. It has been recalled 33 times.

Decided
Apr 6, 2016
Review
13 days
Class
Class II
Product code
IYN
Recalls
33
Predicates
1

Its longest line of descent runs back 16 generations to K935595 (1995). 125 ancestors in all, the oldest K882383 (1988). 100 later devices descend from it, 5 citing it directly. 6 of the 226 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2010: 1 other ancestor2004: 11 other ancestors, 1 with a Class I recall12003: 8 other ancestors2006: 2 other ancestors2002: 14 other ancestors2000: 12 other ancestors, 1 with a Class I recall11999: 11 other ancestors1997: 6 other ancestors2005: 6 other ancestors2001: 10 other ancestors1998: 10 other ancestors, 3 with a Class I recall31996: 3 other ancestors, 1 with a Class I recall11995: 5 other ancestors1994: 5 other ancestors1993: 1 other ancestor1988: 1 other ancestor1992: 1 other ancestor1989: 1 other ancestor2017: 8 descendants cleared2016: 2 descendants cleared2026: 10 descendants cleared2019: 8 descendants cleared2020: 11 descendants cleared2025: 16 descendants cleared2018: 8 descendants cleared2021: 8 descendants cleared2023: 6 descendants cleared2022: 11 descendants cleared2024: 12 descendants clearedK935595 · Acuson Model 3001 · Acuson Corp. · 1995K973767 · Harmonic Imaging with Contrast · Acuson Corp. · 1997K022567 · Sequoia Signature II Diagnostic Ultrasound System · Acuson Corp. · 2002K032114 · Sequoia 8.0 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · 2003×3: 3 generations cleared close together, K041319 (2004), K042770 (2004), K050240 (2005) K052894 · Sonoline G60 S Ultrasound System · Siemens Medical Solutions USA, Inc. · 2005 · recalled×2: 2 generations cleared close together, K063138 (2006), K063803 (2007) K072786 · Acuson S2000 Ultrasound System · Siemens Medical Solutions USA, Inc. · 2007K091970 · Aixplorer Ultrasound System · Supersonic Imagine · 2009K102041 · Aixplorer · Supersonic Imagine · 2010K112255 · Aixplorer · Supersonic Imagine · 2012×2: 2 generations cleared close together, K130499 (2013), K132304 (2013) 1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 4 other ancestors3 generations back: 9 other ancestors4 generations back: 43 other ancestors, 6 with a Class I recall65 generations back: 10 other ancestors6 generations back: 10 other ancestors7 generations back: 7 other ancestors8 generations back: 8 other ancestors9 generations back: 9 other ancestors10 generations back: 9 other ancestors 1 generation forward: 5 descendants2 generations forward: 14 descendants3 generations forward: 15 descendants4 generations forward: 17 descendants5 generations forward: 17 descendants6 generations forward: 15 descendants7 generations forward: 9 descendants8 generations forward: 5 descendants9 generations forward: 3 descendants K132304 · Epiq Diagnostic Ultrasound System · Philips Ultrasound, Inc. · 2013 · recalledK130499 · IU22 Diagnostic Ultrasound System · Philips Ultrasound, Inc. · 2013 · recalledK112255 · Aixplorer · Supersonic Imagine · 2012K102041 · Aixplorer · Supersonic Imagine · 2010K091970 · Aixplorer Ultrasound System · Supersonic Imagine · 2009K072786 · Acuson S2000 Ultrasound System · Siemens Medical Solutions USA, Inc. · 2007K063803 · Acuson Antares Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · recalledK063138 · Modification to Acuson Antares Ultrasound System · Siemens Medical Solutions USA, Inc. · 2006K052894 · Sonoline G60 S Ultrasound System · Siemens Medical Solutions USA, Inc. · 2005 · recalledK050240 · Modification to Acuson CV70 Cardiovascular System · Siemens Medical Solutions USA, Inc. · 2005 · recalledK042770 · Modification to Acuson CV70 Cardiovascular System · Siemens Medical Solutions USA, Inc. · 2004 · recalledK041319 · Sequoia Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · 2004K032114 · Sequoia 8.0 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · 2003K022567 · Sequoia Signature II Diagnostic Ultrasound System · Acuson Corp. · 2002K973767 · Harmonic Imaging with Contrast · Acuson Corp. · 1997K935595 · Acuson Model 3001 · Acuson Corp. · 1995−15−10−50+5
  1. Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
  2. 12 generations between
  3. 3 generations backK112255 AixplorerSupersonic Imagine · 2012
  4. 2 generations backK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
  5. 1 generation backK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
  6. This deviceK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016
  7. Descendant · cites it directly · 58 of its ownK163120 EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2017 · Recalled
  8. Descendant · 2 generations on · 28 of its ownK172607 Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic…Philips Health Care · 2017 · Recalled
  9. Descendant · 3 generations on · 27 of its ownK181485 EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70…Philips Ultrasound, Inc. · 2018 · Recalled
  10. Descendant · cites it directly · 27 of its ownK162329 CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care · 2016 · Recalled
  11. Descendant · 4 generations on · 24 of its ownK200304 EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2020 · Recalled
Show all 16 generations
  1. Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
  2. 15 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
  3. 14 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
  4. 13 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
  5. 12 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
  6. 11 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
  7. 10 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
  8. 9 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
  9. 8 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
  10. 7 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
  11. 6 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
  12. 5 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
  13. 4 generations backK102041 AixplorerSupersonic Imagine · 2010
  14. 3 generations backK112255 AixplorerSupersonic Imagine · 2012
  15. 2 generations backK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
  16. 1 generation backK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
  17. This deviceK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016

Showing 5 of 100 descendants. See all descendants

Descendants cleared per year

2016: 22017: 82018: 82019: 82020: 112021: 82022: 112023: 62024: 122025: 162026: 10
2016high 16 (2025) · low 2 (2016)2026

Class I recalls in this family

  • K040050 Instatrak System with Multiple Dataset…4 generations back · 2004
  • K994270 Instatrak 3000 System with Fluorotrak Module…4 generations back · 2000
  • K983529 Instatrak 30004 generations back · 1998
  • K982994 Skull Base Instatrak System4 generations back · 1998

Most influential descendants

Showing 5 of 100 · See all
  • K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc. · 2017 · cites it directly58descendants
  • K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care · 2017 · 2 generations on28descendants
  • K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2018 · 3 generations on27descendants
  • K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care · 2016 · cites it directly27descendants
  • K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2020 · 4 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K935595Acuson Model 3001Acuson Corp.1995—
−15K973767Harmonic Imaging with ContrastAcuson Corp.1997—
−14K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp.2002—
−13K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2003—
−12K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004—
−11K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20041
−10K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20051
−9K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20051
−8K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006—
−7K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20079
−6K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007—
−5K091970Aixplorer Ultrasound SystemSupersonic Imagine2009—
−4K102041AixplorerSupersonic Imagine2010—
−3K112255AixplorerSupersonic Imagine2012—
−2K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132
−1K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201336
0 (this device)K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System…Philips Ultrasound, Inc.2016—
+1K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System…Philips Ultrasound, Inc.201728
+2K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound…Philips Health Care201731
+3K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic…Philips Ultrasound, Inc.201824
+1K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care20163
+4K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20203

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
198910
199210
199310
199450
199550
199631
199760
1998103
1999110
2000121
2001100
2002140
200380
2004111
200560
200620
201010
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201620
201780
201880
201980
2020110
202180
2022110
202360
2024120
2025160
2026100
FIG. 1 — Lineage of K160807, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

6 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IYN device

  1. #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K132304Epiq Diagnostic Ultrasound System
Summary page 4
…Note 7: Infertility monitoring of follicle development Note 17: PercuNav Note 8: Panoramic Imaging Note 9: Color Power Angio (CPA) Previous submission: K132304, EPIQ…
Philips Ultrasound, Inc.201336

Also cleared against K132304: 11 other devices →

What descends from it? (100)

See all 100

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.201758
K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care201627
K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720
K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179
K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260

Has anything in its family been recalled? (6 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 5, 2025Class IIIZ-1628-2026Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025Class IIIZ-1622-2026Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2411-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2393-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2360-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2389-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2373-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2405-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2367-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2412-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2385-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2403-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2350-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2355-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2402-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2395-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2364-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2380-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2397-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2408-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2410-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2349-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2351-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2347-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
May 28, 2025Class IIZ-2060-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.
May 28, 2025Class IIZ-2048-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.
May 28, 2025Class IIZ-2064-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.
May 28, 2025Class IIZ-2066-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.
May 28, 2025Class IIZ-2063-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.
May 28, 2025Class IIZ-2055-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.
May 28, 2025Class IIZ-2062-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.
May 28, 2025Class IIZ-2065-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.
Aug 30, 2019Class IIZ-1841-2020Process controlThe firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of…

The 5 latest of 33 recalls; the web page lists all.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
  • K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
  • K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
  • K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
  • K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
  • K960330InstatrakVisualization Technology, Inc. · 1996 · 4 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall

Nearest 5 of 6; all are on the web page.

What does this lineage say?

  • The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 11 months on median.
  • 39 of the 125 ancestors have a recall of any class; 6 have a Class I recall.
  • Of its descendants, K163120 (Philips Ultrasound, Inc., 2017) has gone furthest, with 58 descendants of its own.
  • 11 other devices also cite its predicate K132304.

How does its category compare?

All IYN devices

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · IYN

57in 2025

2007: 132008: 252009: 182010: 292011: 392012: 432013: 512014: 562015: 542016: 602017: 642018: 592019: 472020: 572021: 462022: 532023: 442024: 502025: 572026 (partial year): 44
2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007: 26 days median2008: 18 days median2009: 29 days median2010: 67 days median2011: 46 days median2012: 37 days median2013: 60 days median2014: 39 days median2015: 55 days median2016: 56 days median2017: 83 days median2018: 85 days median2019: 79 days median2020: 72 days median2021: 105 days median2022: 105 days median2023: 115 days median2024: 119 days median2025: 124 days median2026 (partial year): 107 days median
2007high 124 (2025) · low 18 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYN

10in 2025

2007: 162008: 122009: 82010: 102011: 82012: 32013: 82014: 22015: 32016: 22018: 72020: 42021: 82022: 102023: 42024: 12025: 102026 (partial year): 2, 1 Class I
2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007: 32008: 22009: 92010: 172011: 182012: 202013: 182014: 482015: 1162016: 1452017: 1462018: 852019: 592020: 672021: 2132022: 1862023: 2292024: 2662025: 610
2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071326163
20082518122
2009182989
201029671017
20113946818
20124337320
20135160818
20145639248
201554553116
201660562145
201764830146
20185985785
20194779059
20205772467
2021461058213
20225310510186
2023441154229
2024501191266
20255712410610
2026441072 (1)—

What is it indicated for?

Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.

The clinical environments where the EPIQ and Affiniti Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K132304

11 other devices cite the same predicate.

  • K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound…Philips Ultrasound, Inc. · 201728 recalls
  • K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care · 201510 recalls
  • K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd. · 2015
  • K150533Terason uSmart3200T Ultrasound SystemTeratech Corp. · 2015
  • K150148Terason uSmart3300 Ultrasound SystemTeratech Corp. · 2015
  • K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2015

More from Philips Ultrasound, Inc.

46 FDA decisions under this applicant name. See the company

  • K212777Collaboration LivePhilips Ultrasound, Inc. · 2021
  • K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 20213 recalls
  • K200603AAA ModelPhilips Ultrasound, Inc. · 2020
  • K201665Collaboration LivePhilips Ultrasound, Inc. · 2020
  • K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc. · 20208 recalls

Recent decisions in IYN

The IYN category page

  • K261585Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10…Samsung Medison Co., Ltd. · 2026
  • K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 2026
  • K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026

https://510kreport.com/device/K160807 · printed Nov 4, 2026

Cite this page

510(k) Report. “K160807: EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160807

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026