510(k) · Cleared
ClearedLogiq A200 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 28, 1996 as substantially equivalent to K863700 (General Electric Co., 1987) after a 190-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Aug 28, 1996
- Review
- 190 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K863700 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK863700 RT2800(115V)/H4008C and RT2800(220/240V)/H4008CEGeneral Electric Co. · 1987
- This deviceK960700 Logiq A200 Diagnostic Ultrasound SystemGE Medical Systems · 1996
- Descendant · cites it directly · 0 of its ownK992208 GE Logiq 200 MD Diagnostic Ultrasound SystemGe Medical Systems, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K992208GE Logiq 200 MD Diagnostic Ultrasound SystemGe Medical Systems, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863700 | RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE | General Electric Co. | 1987 | — |
| 0 (this device) | K960700 | Logiq A200 Diagnostic Ultrasound System | GE Medical Systems | 1996 | — |
| +1 | K992208 | GE Logiq 200 MD Diagnostic Ultrasound System | Ge Medical Systems, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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.
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 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K863700 | RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE Our OCR of the scanned summary read K873700, FDA’s number for Institutional Bili Light (Ibl) (Physician Engineered Products, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GE Medical Systems RT2800 diagnostic ultrasound system”. | 1987 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992208 | GE Logiq 200 MD Diagnostic Ultrasound System | 1999 | 0 |
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?
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The LOGIQ «200 diagnostic ultrasound system is intended for use in diagnostic ultrasound imaging using B, M, and B/M combination modes in the following areas:
Fetal
Abdominal
Intraoperative
Pediatric
Small organs including breast, neck, chest, male and female reproductive organs, limbs, and extremities
Adult Cephalic
Neonatal cephalic
Adult cardiac
Pediatric cardiac
Trans-vaginal
Trans-rectal
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960700 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960700: Logiq A200 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960700
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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