510(k) · Cleared
ClearedGE Logiq 500 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 Dec 22, 1997 as substantially equivalent to K933202 (GE Medical Systems, 1994) after a 286-day review. Its family tree reaches back 1 generation to 1994. 3 of the 1,019 devices in its family, counting itself, have a Class I recall. 1,017 later devices descend from it.
- Decided
- Dec 22, 1997
- Review
- 286 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933202 (1994). 1,017 later devices descend from it, 4 citing it directly. 3 of the 1,019 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK933202 Venus Diagnostic Ultrasound SystemGE Medical Systems · 1994
- This deviceK970901 GE Logiq 500 Diagnostic Ultrasound SystemGE Medical Systems · 1997
- Descendant · cites it directly · 1,015 of its ownK991611 GE Logiq 500General Electric Co. · 1999
- Descendant · 2 generations on · 930 of its ownK040502 Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 3 generations on · 928 of its ownK042833 Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 3 generations on · 927 of its ownK043016 Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 4 generations on · 926 of its ownK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
Showing 5 of 1,017 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,017 · See all- K991611GE Logiq 500General Electric Co. · 1999 · cites it directly1,015descendants
- K040502Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on930descendants
- K042833Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004 · 3 generations on928descendants
- K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 3 generations on927descendants
- K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 4 generations on926descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933202 | Venus Diagnostic Ultrasound System | GE Medical Systems | 1994 | — |
| 0 (this device) | K970901 | GE Logiq 500 Diagnostic Ultrasound System | GE Medical Systems | 1997 | — |
| +1 | K991611 | GE Logiq 500 | General Electric Co. | 1999 | — |
| +2 | K040502 | Sonoline Ebisu Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +3 | K042833 | Sonoline G20 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +3 | K043016 | Sonoline Orchid Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +4 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 10 | 0 |
| 2008 | 11 | 0 |
| 2009 | 19 | 0 |
| 2010 | 18 | 0 |
| 2011 | 27 | 0 |
| 2012 | 34 | 0 |
| 2013 | 42 | 0 |
| 2014 | 51 | 0 |
| 2015 | 59 | 0 |
| 2016 | 64 | 0 |
| 2017 | 79 | 0 |
| 2018 | 70 | 0 |
| 2019 | 55 | 0 |
| 2020 | 78 | 1 |
| 2021 | 54 | 0 |
| 2022 | 60 | 0 |
| 2023 | 60 | 0 |
| 2024 | 66 | 0 |
| 2025 | 84 | 2 |
| 2026 | 58 | 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.
3 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K933202 | Venus Diagnostic Ultrasound SystemSummary page 1…ibed modifications is of a comparable type and substantially equivalent to the ATL HDI 3000 and GE Medical Systems LOGIQ 500 diagnostic ultrasound systems, 510(k) Number K933202, currently in commercial distribution: Device Description: The LOGIQ 500 diagnostic ultrasound system with with the described mo… | 1994 |
| * | — | Atl Hdi 3000 Named without a submission number |
What descends from it? (1,017)
See all 1,0174 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 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 (204 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:
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/K970901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970901: GE Logiq 500 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/K970901
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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