510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2

K082185510(k) SpecialCleared Aug 15, 200814-day reviewClass II21 CFR 892.1560Recalls 1

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

Ge Medical Systems Ultrasound and Primary Care Dia · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Aug 15, 2008 as substantially equivalent to K073408 (Ge Medical Systems Ultrasound and Primary Care Dia, 2007) after a 14-day review. Its family tree reaches back 5 generations to 2001. 627 later devices descend from it. It has been recalled once.

Decided
Aug 15, 2008
Review
14 days
Class
Class II
Product code
IYO
Recalls
1
Predicates
1

Its longest line of descent runs back 5 generations to K010329 (2001). 627 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2009: 3 descendants cleared2018: 53 descendants cleared2015: 32 descendants cleared2011: 13 descendants cleared2010: 5 descendants cleared2013: 25 descendants cleared2012: 23 descendants cleared2014: 36 descendants cleared2016: 43 descendants cleared2017: 55 descendants cleared2020: 53 descendants cleared2023: 41 descendants cleared2019: 38 descendants cleared2021: 39 descendants cleared2022: 45 descendants cleared2025: 47 descendants cleared2026: 31 descendants cleared2024: 45 descendants clearedK010329 · LOGIQ 500 · General Electric Co. · 2001K032182 · GE Logiq 7, Model 2354858 · General Electric Co. · 2003K041813 · GE Logiq 7 Ultrasound BT04 · Ge Medical Systems Ultrasound and Primary Care Dia · 2004K052441 · GE Logiq 7 Ultrasound BT05 · General Electric Co. · 2005K073408 · GE Logiq BT08 Diagnostic Ultrasound System · Ge Medical Systems Ultrasound and Primary Care Dia · 2007200020052010201520202025
Descendants, by generation 1 generation forward: 8 descendants2 generations forward: 33 descendants3 generations forward: 44 descendants4 generations forward: 77 descendants5 generations forward: 96 descendants6 generations forward: 91 descendants7 generations forward: 82 descendants8 generations forward: 60 descendants9 generations forward: 48 descendants10 generations forward: 36 descendants11 generations forward: 23 descendants12 generations forward: 18 descendants13 generations forward: 6 descendants14 generations forward: 5 descendants K073408 · GE Logiq BT08 Diagnostic Ultrasound System · Ge Medical Systems Ultrasound and Primary Care Dia · 2007K052441 · GE Logiq 7 Ultrasound BT05 · General Electric Co. · 2005K041813 · GE Logiq 7 Ultrasound BT04 · Ge Medical Systems Ultrasound and Primary Care Dia · 2004K032182 · GE Logiq 7, Model 2354858 · General Electric Co. · 2003K010329 · LOGIQ 500 · General Electric Co. · 2001−50+5+10
  1. Root · 5 generations backK010329 LOGIQ 500General Electric Co. · 2001
  2. 4 generations backK032182 GE Logiq 7, Model 2354858General Electric Co. · 2003
  3. 3 generations backK041813 GE Logiq 7 Ultrasound BT04Ge Medical Systems Ultrasound and Primary Care Dia · 2004
  4. 2 generations backK052441 GE Logiq 7 Ultrasound BT05General Electric Co. · 2005
  5. 1 generation backK073408 GE Logiq BT08 Diagnostic Ultrasound SystemGe Medical Systems Ultrasound and Primary Care Dia · 2007
  6. This deviceK082185 GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia · 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 627 descendants. See all descendants

Descendants cleared per year

2009: 32010: 52011: 132012: 232013: 252014: 362015: 322016: 432017: 552018: 532019: 382020: 532021: 392022: 452023: 412024: 452025: 472026: 31
2009high 55 (2017) · low 3 (2009)2026

Most influential descendants

Showing 5 of 627 · 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
−5K010329LOGIQ 500General Electric Co.2001—
−4K032182GE Logiq 7, Model 2354858General Electric Co.2003—
−3K041813GE Logiq 7 Ultrasound BT04Ge Medical Systems Ultrasound and Primary Care Dia2004—
−2K052441GE Logiq 7 Ultrasound BT05General Electric Co.2005—
−1K073408GE Logiq BT08 Diagnostic Ultrasound SystemGe Medical Systems Ultrasound and Primary Care Dia2007—
0 (this device)K082185GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia2008—
+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
200930
201050
2011130
2012230
2013250
2014360
2015320
2016430
2017550
2018530
2019380
2020530
2021390
2022450
2023410
2024450
2025470
2026310
FIG. 1 — Lineage of K082185, 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 IYO? 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 IYO device

  1. #1 K243937 Accuro 3Sscore 20.5 · 18 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
*K073408GE Logiq BT08 Diagnostic Ultrasound System
Summary page 1
…892.1560, 90-IYO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: GE LOGIQBT08 Diagnostic Ultrasound System K073408. 4. Device Description: The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobil…
Ge Medical Systems Ultrasound and Primary Care Dia2007—

What descends from it? (627)

See all 627

8 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
K093466HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusHitachi Medical Systems America, Inc.201096
K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979
K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco200961
K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321
K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813
K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513
K090754LipocontrolOsyris Medical20110

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 22, 2018Class IIZ-2983-2018Component design/selectionThe system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K092271 (GE Healthcare, 2009) has gone furthest, with 569 descendants of its own.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, 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
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

What is it indicated for?

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Indications for use as stated in the FDA summary.

More from Ge Medical Systems Ultrasound and…

7 FDA decisions under this applicant name. See the company

  • K103730GE Lunar Visceral Fat SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2011
  • K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
  • K073408GE Logiq BT08 Diagnostic Ultrasound SystemGe Medical Systems Ultrasound and Primary Care Dia · 2007
  • K072439GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile KitGe Medical Systems Ultrasound and Primary Care Dia · 2007
  • K052581Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia · 20051 recall

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The IYO category page

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https://510kreport.com/device/K082185 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082185: GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082185

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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