510(k) · Cleared
Recalled · Class II · 2025ClearVue850 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Health Care · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 16, 2015 as substantially equivalent to K120321 (Philips Health Care, 2012) and 1 other predicate after a 14-day review. Its family tree reaches back 16 generations to 1995. 6 of the 130 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 10 times.
- Decided
- Dec 16, 2015
- Review
- 14 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 10
- Predicates
- 2
Its longest line of descent runs back 16 generations to K935595 (1995). 127 ancestors in all, the oldest K882383 (1988). 2 later devices descend from it, 1 citing it directly. 6 of the 130 devices in this family, counting this one, have a Class I recall.
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations between
- 3 generations backK112255 AixplorerSupersonic Imagine · 2012
- 2 generations backK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 1 generation backK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- This deviceK153480 ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care · 2015
- Descendant · cites it directly · 1 of its ownK163020 Xperius Ultrasound SystemPhilips Health Care · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK182529 Xperius Ultrasound SystemPhilips Ultrasound, Inc. · 2018
Show all 16 generations
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 14 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 13 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 12 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 11 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 10 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 7 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 6 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 4 generations backK102041 AixplorerSupersonic Imagine · 2010
- 3 generations backK112255 AixplorerSupersonic Imagine · 2012
- 2 generations backK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 1 generation backK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- This deviceK153480 ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care · 2015
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −15 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −14 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −13 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −12 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −11 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −10 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −7 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −6 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| −4 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| −3 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| −2 | K130499 | IU22 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 2 |
| −1 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| 0 (this device) | K153480 | ClearVue850 Diagnostic Ultrasound System | Philips Health Care | 2015 | — |
| +1 | K163020 | Xperius Ultrasound System | Philips Health Care | 2016 | 1 |
| +2 | K182529 | Xperius Ultrasound System | Philips Ultrasound, Inc. | 2018 | — |
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 | 7 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 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.
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 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? (2)
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 |
|---|---|---|---|
| * | K120321 | Clearvue 350/550 Diagnostic Ultrasound SystemSummary page 5…P P P P Note: 1,2,3 Note: 5,6, 7, 8,9,10,11 Vessel Cerebral Vascular N= new indication; P= previously cleared by FDA K120321 Additional Comments: *Color Doppler includes Color Amplitude Doppler Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;… | 2012 |
| * | K132304 | Epiq Diagnostic Ultrasound SystemSummary page 10…1,2,3,15 Vessel Cerebral Vascular N= new indication; P= previously cleared by FDA K132304 Additional Comments: *Color Doppler includes Color Amplitude Doppler Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;… | 2013 |
| † | K141261 | Logiq S7 Expert, Logiq S7 Pro | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163020 | Xperius Ultrasound System | 2016 | 1 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2025 | Class III | Z-1625-2026 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2373-2025 | 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-2375-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2364-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2347-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2391-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| May 28, 2025 | Class II | Z-2048-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Class II | Z-2055-2025 | 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. |
The 5 latest of 10 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 20 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 41 of the 127 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K163020 (Philips Health Care, 2016) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K120321.
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. 2015, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 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?
The ClearVue850 Diagnostic Ultrasound system is a general purpose, portable, cart based ultrasound system, intended for use by customers in various clinical settings (private offices, clinics, small hospitals, large hospitals, primary and community healthcare centers) by different users (General Practitioners, Paraprofessionals, physician specialists including OBG’s, Ultrasound Lab physicians, and nurse practitioners, etc., The System is intended for…
Read the full statement (150 words)
The ClearVue850 Diagnostic Ultrasound system is a general purpose, portable, cart based ultrasound system, intended for use by customers in various clinical settings (private offices, clinics, small hospitals, large hospitals, primary and community healthcare centers) by different users (General Practitioners, Paraprofessionals, physician specialists including OBG’s, Ultrasound Lab physicians, and nurse practitioners, etc.,
The System is intended for diagnostic ultrasound imaging in the following modes: B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Harmonics, iSCAN, X-Res, Angio, 3D (freehand), 4D and SonoCT, Combined modes includes FloVue, Elastography (strain).
The system is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications, as listed in FDA’s Diagnostic Ultrasound Indications for Use Form section 1.3 which includes Fetal / OB, Abdominal,Pediatric,Small Organ (breast, thyroid, testicle),Neonatal Cephalic,Adult Cephalic,Trans-rectal, Trans-vaginal,Musculo-skel. (Conventional), Musculo-skel. (Superficial),Other: GYN,Other: Urology,Cardiac Adult,Cardiac Pediatric,Trans-esophageal (Cardiac),Other (Fetal Echo),Peripheral vessel and Cerebral Vascular.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153480: ClearVue850 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/K153480
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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