510(k) · Cleared
ClearedGE Logiq 9 Ultrasound BT03/IQ, Model 2375600-X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Oct 30, 2003 as substantially equivalent to K011188 (GE Medical Systems, 2001) and 1 other predicate after a 63-day review. Its family tree reaches back 2 generations to 2001. 432 later devices descend from it.
- Decided
- Oct 30, 2003
- Review
- 63 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011188 (2001). 432 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011188 GE Logiq 9, Model 2188900-XGE Medical Systems · 2001
- 1 generation backK030934 GE Logiq 9 Model 2375600Ge Medical Systems, Inc. · 2003
- This deviceK032656 GE Logiq 9 Ultrasound BT03/IQ, Model 2375600-XGe Med. Systems Ultrasound & Prim. Care Diag.,Llc · 2003
- Descendant · cites it directly · 431 of its ownK040251 GE Logiq 9 Diagnostic Ultrasound System, Model 2404587Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc · 2004
- Descendant · cites it directly · 430 of its ownK061129 GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000General Electric Co. · 2006 · Recalled
- Descendant · 2 generations on · 247 of its ownK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
- Descendant · 3 generations on · 216 of its ownK113156 Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · Recalled
- Descendant · 2 generations on · 188 of its ownK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
Showing 5 of 432 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 432 · See all- K040251GE Logiq 9 Diagnostic Ultrasound System, Model 2404587Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc · 2004 · cites it directly431descendants
- K061129GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000General Electric Co. · 2006 · cites it directly430descendants
- K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · 2 generations on247descendants
- K113156Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · 3 generations on216descendants
- K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 2 generations on188descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011188 | GE Logiq 9, Model 2188900-X | GE Medical Systems | 2001 | — |
| −1 | K030934 | GE Logiq 9 Model 2375600 | Ge Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K032656 | GE Logiq 9 Ultrasound BT03/IQ, Model 2375600-X | Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc | 2003 | — |
| +1 | K040251 | GE Logiq 9 Diagnostic Ultrasound System, Model 2404587 | Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc | 2004 | — |
| +1 | K061129 | GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000 | General Electric Co. | 2006 | 1 |
| +2 | K082098 | Sonosite Maxx Series Ultrasound System | Sonosite,Inc. | 2008 | 2 |
| +3 | K113156 | Sonosite Edge Ultrasound System | Sonosite,Inc. | 2011 | 1 |
| +2 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 12 | 0 |
| 2012 | 8 | 0 |
| 2013 | 15 | 0 |
| 2014 | 7 | 0 |
| 2015 | 27 | 0 |
| 2016 | 26 | 0 |
| 2017 | 44 | 0 |
| 2018 | 30 | 0 |
| 2019 | 31 | 0 |
| 2020 | 40 | 0 |
| 2021 | 29 | 0 |
| 2022 | 36 | 0 |
| 2023 | 23 | 0 |
| 2024 | 30 | 0 |
| 2025 | 33 | 0 |
| 2026 | 21 | 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.
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 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 |
|---|---|---|---|
| * | K011188 | GE Logiq 9, Model 2188900-X | 2001 |
| * | K030934 | GE Logiq 9 Model 2375600Summary page 1….1560, 90-IYO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: GE LOGlQ 9 Diagnostic Ultrasound System KO1 1188/K030934 (90-IYO/IYN) A device currently in commercial distribution. 4. Device Description: The GE LOGIQ 9 is a full f… | 2003 |
What descends from it? (432)
See all 4322 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K040251 (Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc, 2004) has gone furthest, with 431 descendants of its own.
- 6 other devices also cite its predicate K011188.
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.
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 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; and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032656: GE Logiq 9 Ultrasound BT03/IQ, Model 2375600-X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032656
Report an extraction error
Are you the manufacturer?
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