510(k) · Cleared
Recalled · Class II · 2025Epiq Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Ultrasound, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 21, 2013 as substantially equivalent to K130499 (Philips Ultrasound, Inc., 2013) and 4 other predicates after a 28-day review. Its family tree reaches back 15 generations to 1995. 8 of the 336 devices in its family, counting itself, have a Class I recall. 211 later devices descend from it. It has been recalled 36 times.
- Decided
- Aug 21, 2013
- Review
- 28 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 36
- Predicates
- 5
Its longest line of descent runs back 15 generations to K935595 (1995). 124 ancestors in all, the oldest K882383 (1988). 211 later devices descend from it, 12 citing it directly. 8 of the 336 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations between
- 3 generations backK102041 AixplorerSupersonic Imagine · 2010
- 2 generations backK112255 AixplorerSupersonic Imagine · 2012
- 1 generation backK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- This deviceK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013
- Descendant · cites it directly · 100 of its ownK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016 · Recalled
- Descendant · cites it directly · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 79 of its ownK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- Descendant · cites it directly · 58 of its ownK163120 EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 43 of its ownK162549 Lumify Ultrasound SystemPhilips Health Care · 2016 · Recalled
Show all 15 generations
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 13 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 12 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 11 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 9 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 6 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 5 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 3 generations backK102041 AixplorerSupersonic Imagine · 2010
- 2 generations backK112255 AixplorerSupersonic Imagine · 2012
- 1 generation backK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- This deviceK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013
Showing 5 of 211 descendants. See all descendants
Descendants cleared per year
2014high 25 (2025) · low 4 (2014)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 211 · See all- K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc. · 2016 · cites it directly100descendants
- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · cites it directly87descendants
- K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · 2 generations on79descendants
- K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc. · 2017 · cites it directly58descendants
- K162549Lumify Ultrasound SystemPhilips Health Care · 2016 · 3 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −14 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −13 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −12 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −11 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −9 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −6 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −5 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| −3 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| −2 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| −1 | K130499 | IU22 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 2 |
| 0 (this device) | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | — |
| +1 | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System… | Philips Ultrasound, Inc. | 2016 | 33 |
| +1 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| +2 | K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015 | 4 |
| +1 | K163120 | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System… | Philips Ultrasound, Inc. | 2017 | 28 |
| +3 | K162549 | Lumify Ultrasound System | Philips Health Care | 2016 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 1 |
| 1997 | 6 | 0 |
| 1998 | 10 | 3 |
| 1999 | 11 | 0 |
| 2000 | 12 | 1 |
| 2001 | 10 | 0 |
| 2002 | 14 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 1 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 4 | 0 |
| 2015 | 13 | 0 |
| 2016 | 13 | 0 |
| 2017 | 23 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 19 | 0 |
| 2021 | 19 | 0 |
| 2022 | 20 | 0 |
| 2023 | 14 | 0 |
| 2024 | 18 | 0 |
| 2025 | 25 | 2 |
| 2026 | 19 | 0 |
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.
8 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 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130499 | IU22 Diagnostic Ultrasound SystemSummary page 2…itry, memory, and essential hardware. While this hardware is new, the intended use and indications for use of the device remain unchanged from the Predicate iU22 system (K130499, K(121498, K(093563, 1(042540,K1(30455). Page 15… | 2013 |
| * | K121498 | PercunavSummary page 2…y, and essential hardware. While this hardware is new, the intended use and indications for use of the device remain unchanged from the Predicate iU22 system (K130499, K(121498, K(093563, 1(042540,K1(30455). Page 15 of 121 ==… | 2012 |
| * | K093563 | IU22 Ultrasound System and TransducersSummary page 2…ential hardware. While this hardware is new, the intended use and indications for use of the device remain unchanged from the Predicate iU22 system (K130499, K(121498, K(093563, 1(042540,K1(30455). Page 15 of 121 === Page 3 =… | 2010 |
| * | K042540 | Philips IU22 Ultrasound SystemSummary page 2…dware. While this hardware is new, the intended use and indications for use of the device remain unchanged from the Predicate iU22 system (K130499, K(121498, K(093563, 1(042540,K1(30455). Page 15 of 121 Both th… | 2004 |
| * | K030455 | Boris Platform Diagnostic Ultrasound SystemSummary page 1…ct I510(k) Philips iU22 Diagnostic Ultrasound System 1(130499,Kl(21498,K1(93563,K1(42540, 1(030455 Page 14 of 121 4. Device Description… | 2003 |
What descends from it? (211)
See all 21112 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50… | 2016 | 100 |
| K133833 | Nuvis Diagnostic Ultrasound System | 2014 | 87 |
| K163120 | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50… | 2017 | 58 |
| K142710 | S9 Portable Digital Color Doppler Ultrasound System | 2015 | 19 |
| K150773 | E-CUBE 15 Diagnostic Ultrasound System | 2015 | 15 |
| K142714 | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System | 2015 | 4 |
| K142474 | S12 Digital Color Doppler Ultrasound System | 2014 | 4 |
| K153480 | ClearVue850 Diagnostic Ultrasound System | 2015 | 2 |
| K150533 | Terason uSmart3200T Ultrasound System | 2015 | 2 |
| K142815 | S22 Digital Color Doppler Ultrasound System | 2015 | 2 |
Has anything in its family been recalled? (8 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2025 | Class III | Z-1622-2026 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2360-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2389-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2352-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2377-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2367-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2412-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2385-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2403-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2378-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2350-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2402-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2395-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2380-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2397-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2359-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2408-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2410-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2351-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| May 28, 2025 | Class II | Z-2060-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Class II | Z-2064-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Class II | Z-2066-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Class II | Z-2062-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Class II | Z-2049-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Class II | Z-2065-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
| Jun 30, 2023 | Class II | Z-2517-2023 | Process control | Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in… |
| Mar 28, 2016 | Class II | Z-1380-2016 | Device Design | The fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound System may loosen over time, which could subsequently lead to the detachment of the entire assembly from the ultrasound system. |
| Apr 14, 2015 | Class II | Z-1632-2015 | Software design | When EPIQ 7 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to "Metric" and weight and/or height is entered, a unit conversion error may result in the incorrect display of their values and incorrect calculation of… |
| Apr 14, 2015 | Class II | Z-1631-2015 | Software design | When EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to "Metric" and weight and/or height is entered, a unit conversion error may result in the incorrect display of their values and incorrect calculation of… |
| Apr 10, 2015 | Class II | Z-1579-2015 | Software design | When Epiq 7 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patients Body Surface Area (BSA). |
| Apr 10, 2015 | Class II | Z-1578-2015 | Software design | When Epiq 5 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patients Body Surface Area (BSA). |
| Nov 5, 2014 | Class II | Z-0816-2015 | Software design | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the… |
| Nov 5, 2014 | Class II | Z-0817-2015 | Software design | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the… |
| Feb 28, 2014 | Class II | Z-1263-2014 | Software design | A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse… |
| Feb 28, 2014 | Class II | Z-1264-2014 | Software design | A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse… |
| Oct 17, 2013 | Class II | Z-0368-2014 | Software design | A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established… |
The 5 latest of 36 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 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 38 of the 124 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K160807 (Philips Ultrasound, Inc., 2016) has gone furthest, with 100 descendants of its own.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2007high 64 (2017) · low 13 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
2007high 124 (2025) · low 18 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
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
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
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
Fetal/Obstetric
Gynecological
Intra-operative (Vascular, Cardiac)
Abdominal
Pediatric
Small Organ (Breast, Thyroid, Testicle)
Cephalic (Adult, Neonatal)
Trans-rectal
Trans-vaginal
Musculoskeletal (Conventional and Superficial)
Urology
Cardiac (Adult, Pediatric, Fetal, Trans-esophageal)
Fetal Echo
Peripheral Vessel
Vascular (Cerebral)
The clinical environments where the EPIQ Diagnostic Ultrasound System can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132304: Epiq Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132304
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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