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 · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Oct 3, 1997 as substantially equivalent to K930768 (GE Medical Systems, 1994) after a 340-day review. Its family tree reaches back 1 generation to 1994. 217 later devices descend from it.
- Decided
- Oct 3, 1997
- Review
- 340 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930768 (1994). 217 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK930768 Orion Diagnostic Ultrasound SystemGE Medical Systems · 1994
- This deviceK964617 GE Logiq 700 Diagnostic Ultrasound SystemGE Medical Systems · 1997
- Descendant · cites it directly · 213 of its ownK990248 Dicom Image Manager, Model 3-D Visualization OptionDicomit Imaging Systems Corp. · 1999
- Descendant · 2 generations on · 212 of its ownK992886 Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C · 1999
- Descendant · 3 generations on · 211 of its ownK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- Descendant · 3 generations on · 210 of its ownK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
- Descendant · 4 generations on · 209 of its ownK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
Showing 5 of 217 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 217 · See all- K990248Dicom Image Manager, Model 3-D Visualization OptionDicomit Imaging Systems Corp. · 1999 · cites it directly213descendants
- K992886Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C · 1999 · 2 generations on212descendants
- K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001 · 3 generations on211descendants
- K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · 3 generations on210descendants
- K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003 · 4 generations on209descendants
View 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) | K964617 | GE Logiq 700 Diagnostic Ultrasound System | GE Medical Systems | 1997 | — |
| +1 | K990248 | Dicom Image Manager, Model 3-D Visualization Option | Dicomit Imaging Systems Corp. | 1999 | — |
| +2 | K992886 | Powerview Ultrasound Workstation, Uidm-400A | Toshiba America Medical Systems, In.C | 1999 | — |
| +3 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| +3 | K022400 | Ssa-700A, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2002 | 1 |
| +4 | K032281 | Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 4 | 0 |
| 2014 | 10 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 12 | 0 |
| 2018 | 18 | 0 |
| 2019 | 8 | 0 |
| 2020 | 20 | 0 |
| 2021 | 9 | 0 |
| 2022 | 16 | 0 |
| 2023 | 18 | 0 |
| 2024 | 13 | 0 |
| 2025 | 26 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K930768 | Orion Diagnostic Ultrasound SystemSummary page 1…Diagnostic Ultrasound System with 3D 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 diagnostic ultrasound system with 3D is the same in all… | 1994 |
What descends from it? (217)
See all 2174 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 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?
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the…
Read the full statement (144 words)
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
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/K964617 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964617: 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/K964617
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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