510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

HD11 Diagnostic Ultrasound System

K062247510(k) SpecialCleared Aug 18, 200615-day reviewClass II21 CFR 892.1550Recalls 3

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 Aug 18, 2006 as substantially equivalent to K031066 (Ep Medsystems, 2003) after a 15-day review. Its family tree reaches back 1 generation to 2003. 687 later devices descend from it. It has been recalled 3 times.

Decided
Aug 18, 2006
Review
15 days
Class
Class II
Product code
IYN
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K031066 (2003). 687 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2008: 7 descendants cleared2012: 23 descendants cleared2009: 6 descendants cleared2007: 1 descendant cleared2010: 11 descendants cleared2018: 55 descendants cleared2013: 23 descendants cleared2015: 39 descendants cleared2019: 38 descendants cleared2017: 63 descendants cleared2011: 16 descendants cleared2014: 35 descendants cleared2016: 43 descendants cleared2020: 55 descendants cleared2025: 57 descendants cleared2021: 39 descendants cleared2026: 39 descendants cleared2022: 46 descendants cleared2023: 41 descendants cleared2024: 50 descendants clearedK031066 · Viewmate Ultrasound Imaging System · Ep Medsystems · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 8 descendants2 generations forward: 30 descendants3 generations forward: 60 descendants4 generations forward: 61 descendants5 generations forward: 75 descendants6 generations forward: 98 descendants7 generations forward: 90 descendants8 generations forward: 76 descendants9 generations forward: 68 descendants10 generations forward: 44 descendants11 generations forward: 39 descendants12 generations forward: 17 descendants13 generations forward: 9 descendants14 generations forward: 6 descendants15 generations forward: 5 descendants16 generations forward: 1 descendant K031066 · Viewmate Ultrasound Imaging System · Ep Medsystems · 20030+5+10+15
  1. Root · 1 generation backK031066 Viewmate Ultrasound Imaging SystemEp Medsystems · 2003
  2. This deviceK062247 HD11 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2006
  3. Descendant · cites it directly · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
  4. Descendant · cites it directly · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
  5. Descendant · 2 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
  6. Descendant · 3 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled
  7. Descendant · 4 generations on · 469 of its ownK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled

Showing 5 of 687 descendants. See all descendants

Descendants cleared per year

2007: 12008: 72009: 62010: 112011: 162012: 232013: 232014: 352015: 392016: 432017: 632018: 552019: 382020: 552021: 392022: 462023: 412024: 502025: 572026: 39
2007high 63 (2017) · low 1 (2007)2026

Most influential descendants

Showing 5 of 687 · See all
  • K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · cites it directly584descendants
  • K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · cites it directly582descendants
  • K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 2 generations on569descendants
  • K110943Logiq E9GE Healthcare · 2011 · 3 generations on472descendants
  • K113690GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · 4 generations on469descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K031066Viewmate Ultrasound Imaging SystemEp Medsystems2003—
0 (this device)K062247HD11 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2006—
+1K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008—
+1K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008—
+2K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20091
+3K110943Logiq E9GE Healthcare20112
+4K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200870
200960
2010110
2011160
2012230
2013230
2014350
2015390
2016430
2017630
2018550
2019380
2020550
2021390
2022460
2023410
2024500
2025570
2026390
FIG. 1 — Lineage of K062247, 2003–2026Source: 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.

Planning a device in IYN? 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? (3)

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
*K031066Viewmate Ultrasound Imaging System
Summary page 5
…C5-2 (K043535) renamed to C6-3, 3D6-2 (K043535) renamed to V6-2, 3D8-4 (K043535) renamed to V8-4 and the addition of the EP MedSystems ViewFlexTM catheter (K031066). 4.2.13 Track This is a Track 3 system. The 5 10(k) Special Report will be submitted prior to domestic shipment…
Ep Medsystems2003—
*—Philips M2540A EnVisor Ultrasound system
Named without a submission number
—
*—Philips HDI-5000 series Ultrasound systems
Named without a submission number
—

Also cleared against K031066: 4 other devices →

What descends from it? (687)

See all 687

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

NumberDeviceApplicantDecidedDescendants
K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008584
K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582
K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007188
K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132
K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979
K123754CX50 3.0 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201253
K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821
K081661HD15 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20080

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
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-2356-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
May 28, 2025Class IIZ-2062-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K080935 (Ultrasonix Medical Corporation, 2008) has gone furthest, with 584 descendants of its own.
  • 4 other devices also cite its predicate K031066.

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.

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?

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for use as stated in the FDA summary.

Also cleared against K031066

4 other devices cite the same predicate.

  • K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc. · 2010
  • K073709Modification to Viewmate SystemEp Medsystems · 2008
  • K071028Viewmate SystemEp Medsystems · 2007
  • K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc. · 2006

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/K062247 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062247: HD11 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/K062247

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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