510(k) Report

510(k) · Cleared

Cleared

GE Vivid E9 Ultrasound

K081921510(k) SpecialCleared Aug 6, 200830-day reviewClass II21 CFR 892.1550

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

General Electric Co. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Aug 6, 2008 as substantially equivalent to K003931 (Ge Medical Systems, Inc., 2001) and 4 other predicates after a 30-day review. Its family tree reaches back 5 generations to 2001. 579 later devices descend from it.

Decided
Aug 6, 2008
Review
30 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K003931 (2001). 579 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2010: 4 descendants cleared2012: 24 descendants cleared2009: 1 descendant cleared2011: 9 descendants cleared2014: 32 descendants cleared2013: 21 descendants cleared2018: 48 descendants cleared2015: 29 descendants cleared2017: 48 descendants cleared2016: 37 descendants cleared2020: 51 descendants cleared2025: 46 descendants cleared2024: 45 descendants cleared2023: 38 descendants cleared2022: 42 descendants cleared2019: 35 descendants cleared2021: 38 descendants cleared2026: 31 descendants clearedK003931 · Vivid 7 with Sonopac, Model FB0008XX · Ge Medical Systems, Inc. · 2001K031663 · GE Vivid 7, Model FC0003XX · General Electric Co. · 2003K041552 · GE Vivid 7 BT04 · General Electric Co. · 2004K051449 · GE Vivid 7 with or Without Suffix · GE Medical Systems · 2005K060542 · GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX · General Electric Co. · 2006 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 17 descendants3 generations forward: 39 descendants4 generations forward: 81 descendants5 generations forward: 88 descendants6 generations forward: 91 descendants7 generations forward: 77 descendants8 generations forward: 62 descendants9 generations forward: 40 descendants10 generations forward: 23 descendants11 generations forward: 20 descendants12 generations forward: 14 descendants13 generations forward: 14 descendants14 generations forward: 8 descendants15 generations forward: 1 descendant K060542 · GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX · General Electric Co. · 2006 · recalledK051449 · GE Vivid 7 with or Without Suffix · GE Medical Systems · 2005K041552 · GE Vivid 7 BT04 · General Electric Co. · 2004K031663 · GE Vivid 7, Model FC0003XX · General Electric Co. · 2003K003931 · Vivid 7 with Sonopac, Model FB0008XX · Ge Medical Systems, Inc. · 2001−50+5+10+15
  1. Root · 5 generations backK003931 Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc. · 2001
  2. 4 generations backK031663 GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003
  3. 3 generations backK041552 GE Vivid 7 BT04General Electric Co. · 2004
  4. 2 generations backK051449 GE Vivid 7 with or Without SuffixGE Medical Systems · 2005
  5. 1 generation backK060542 GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XXGeneral Electric Co. · 2006 · Recalled
  6. This deviceK081921 GE Vivid E9 UltrasoundGeneral Electric Co. · 2008
  7. Descendant · cites it directly · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
  8. Descendant · 2 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled
  9. Descendant · 3 generations on · 469 of its ownK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
  10. Descendant · 2 generations on · 367 of its ownK111582 Logiq S8GE Healthcare · 2011 · Recalled
  11. Descendant · 3 generations on · 365 of its ownK122327 Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012

Showing 5 of 579 descendants. See all descendants

Descendants cleared per year

2009: 12010: 42011: 92012: 242013: 212014: 322015: 292016: 372017: 482018: 482019: 352020: 512021: 382022: 422023: 382024: 452025: 462026: 31
2009high 51 (2020) · low 1 (2009)2026

Most influential descendants

Showing 5 of 579 · See all
  • K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · cites it directly569descendants
  • K110943Logiq E9GE Healthcare · 2011 · 2 generations on472descendants
  • K113690GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · 3 generations on469descendants
  • K111582Logiq S8GE Healthcare · 2011 · 2 generations on367descendants
  • K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012 · 3 generations on365descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K003931Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc.2001—
−4K031663GE Vivid 7, Model FC0003XXGeneral Electric Co.2003—
−3K041552GE Vivid 7 BT04General Electric Co.2004—
−2K051449GE Vivid 7 with or Without SuffixGE Medical Systems2005—
−1K060542GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XXGeneral Electric Co.20061
0 (this device)K081921GE Vivid E9 UltrasoundGeneral Electric Co.2008—
+1K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20091
+2K110943Logiq E9GE Healthcare20112
+3K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20111
+2K111582Logiq S8GE Healthcare20113
+3K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201040
201190
2012240
2013210
2014320
2015290
2016370
2017480
2018480
2019350
2020510
2021380
2022420
2023380
2024450
2025460
2026310
FIG. 1 — Lineage of K081921, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K003931Vivid 7 with Sonopac, Model FB0008XX
Summary page 1
…g System, 21 CFR 892.1550, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Vivid 7 Diagnostic Ultrasound K003931/K031663/K041552/K051449/K060542 (90-IYO/IYN/ITX) A device currently in commercial distribution. 4. Device D…
Ge Medical Systems, Inc.2001—
*K031663GE Vivid 7, Model FC0003XX
Summary page 1
…, 21 CFR 892.1550, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Vivid 7 Diagnostic Ultrasound K003931/K031663/K041552/K051449/K060542 (90-IYO/IYN/ITX) A device currently in commercial distribution. 4. Device Descripti…
General Electric Co.2003—
*K041552GE Vivid 7 BT04
Summary page 1
…892.1550, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Vivid 7 Diagnostic Ultrasound K003931/K031663/K041552/K051449/K060542 (90-IYO/IYN/ITX) A device currently in commercial distribution. 4. Device Description: The…
General Electric Co.2004—
*K051449GE Vivid 7 with or Without Suffix
Summary page 1
…0, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Vivid 7 Diagnostic Ultrasound K003931/K031663/K041552/K051449/K060542 (90-IYO/IYN/ITX) A device currently in commercial distribution. 4. Device Description: The GE Vivid…
GE Medical Systems2005—
*K060542GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX
Summary page 1
…N Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Vivid 7 Diagnostic Ultrasound K003931/K031663/K041552/K051449/K060542 (90-IYO/IYN/ITX) A device currently in commercial distribution. 4. Device Description: The GE Vivid E9 Ultr…
General Electric Co.20061

Also cleared against K003931: 4 other devices →

What descends from it? (579)

See all 579

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

NumberDeviceApplicantDecidedDescendants
K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare2009569
K101149GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS2010350
K120201GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS2012253
K101324GE Echopac Model BT10Ge Vingmed Ultrasound AS2010172

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K092271 (GE Healthcare, 2009) has gone furthest, with 569 descendants of its own.
  • 4 other devices also cite its predicate K003931.

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. 2008, 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?

The device is intended for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Indications for use as stated in the FDA summary.

Also cleared against K003931

4 other devices cite the same predicate.

  • K060542GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XXGeneral Electric Co. · 20061 recall
  • K051449GE Vivid 7 with or Without SuffixGE Medical Systems · 2005
  • K041552GE Vivid 7 BT04General Electric Co. · 2004
  • K031663GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003

More from General Electric Co.

270 FDA decisions under this applicant name. See the company

  • K103489GE Veo Reconstruction OptionGeneral Electric Co. · 2011
  • K082317GE Lunar Frax 10-Year Fracture Risk Software OptionGeneral Electric Co. · 2008
  • K073297GE Logiq P6General Electric Co. · 20072 recalls
  • K072952GE EchopacGeneral Electric Co. · 2007
  • K072797GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact UltrasoundGeneral Electric Co. · 2007

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/K081921 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081921: GE Vivid E9 Ultrasound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081921

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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