510(k) · Cleared
ClearedGE LOGIQ700 Diagnostic Ultrasound System with B-Flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Feb 9, 1999 as substantially equivalent to K930768 (GE Medical Systems, 1994) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 9, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930768 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK930768 Orion Diagnostic Ultrasound SystemGE Medical Systems · 1994
- 1 generation backK960527 Logiq 1000 Diagnostic Ultrsound SystemGE Medical Systems · 1997
- This deviceK990226 GE LOGIQ700 Diagnostic Ultrasound System with B-FlowGe Medical Systems, Inc. · 1999
- 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 |
|---|---|---|---|---|---|
| −2 | K930768 | Orion Diagnostic Ultrasound System | GE Medical Systems | 1994 | — |
| −1 | K960527 | Logiq 1000 Diagnostic Ultrsound System | GE Medical Systems | 1997 | — |
| 0 (this device) | K990226 | GE LOGIQ700 Diagnostic Ultrasound System with B-Flow | Ge Medical Systems, Inc. | 1999 | — |
| +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 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? (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 |
|---|---|---|---|
| * | K930768 | Orion Diagnostic Ultrasound SystemSummary page 1…dification. Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO 3. Marketed Device: GE Medical Systems LOGIQ 700 diagnostic ultrasound system, 510(k) Numbers K930768 and K960527, currently in commercial distribution. 4. Device Description: The LOGIQ 700 with B-flow consists of a mobile console… | 1994 |
| * | K960527 | Logiq 1000 Diagnostic Ultrsound SystemSummary page 1…Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO 3. Marketed Device: GE Medical Systems LOGIQ 700 diagnostic ultrasound system, 510(k) Numbers K930768 and K960527, currently in commercial distribution. 4. Device Description: The LOGIQ 700 with B-flow consists of a mobile console approximate… | 1997 |
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K993365 (Ge Medical Systems, Inc., 1999) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K930768.
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 700 with B-flow is a general purpose ultrasound imaging system intended for use in the evaluation of soft tissue and vascular disease in the head, neck, chest, abdomen, pelvis, male and female reproductive organs, limbs and pregnant uterus.
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/K990226 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990226: GE LOGIQ700 Diagnostic Ultrasound System with B-Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990226
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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