510(k) · Cleared
ClearedGE Logiq 700 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jul 29, 1997 as substantially equivalent to K930768 (GE Medical Systems, 1994) after a 235-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Jul 29, 1997
- Review
- 235 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930768 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK930768 Orion Diagnostic Ultrasound SystemGE Medical Systems · 1994
- This deviceK964886 GE Logiq 700 Diagnostic Ultrasound SystemGE Medical Systems · 1997
- Descendant · cites it directly · 0 of its ownK993365 GE Logiq 700 with Harmonic Imaging ModificationGe Medical Systems, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK993364 GE Logiq 700 with Coded Excitation ModificationGe Medical Systems, Inc. · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930768 | Orion Diagnostic Ultrasound System | GE Medical Systems | 1994 | — |
| 0 (this device) | K964886 | GE Logiq 700 Diagnostic Ultrasound System | GE Medical Systems | 1997 | — |
| +1 | K993365 | GE Logiq 700 with Harmonic Imaging Modification | Ge Medical Systems, Inc. | 1999 | — |
| +1 | K993364 | GE Logiq 700 with Coded Excitation Modification | Ge Medical Systems, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 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? (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 |
|---|---|---|---|
| * | K930768 | Orion Diagnostic Ultrasound SystemSummary page 4…tra-operative and neurosurgical uses is of a comparable type and substantially equivalent to the GE Medical Systems LOGIQ 700 diagnostic ultrasound system, 510(k) Number K930768, currently in commercial distribution: Device Description: The LOGIQ 700 including intra-operative and neurosurgical uses is the… | 1994 |
What descends from it? (2)
2 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?
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?
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Other Indications or Modes: Small organ includes breast, testes, thyroid. Intra-operative includes abdominal organs. Combined modes are BM, B/Color, B/PWD, B/Color/PWD.
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/K964886 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964886: GE Logiq 700 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964886
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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