510(k) · Cleared
ClearedGE Logiq A100 MP, Model 2272413
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 23, 2001 as substantially equivalent to K953752 (General Electric Co., 1996) after a 15-day review. Its family tree reaches back 2 generations to 1987. 2 of the 671 devices in its family, counting itself, have a Class I recall. 668 later devices descend from it.
- Decided
- Aug 23, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K863700 (1987). 668 later devices descend from it, 1 citing it directly. 2 of the 671 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK863700 RT2800(115V)/H4008C and RT2800(220/240V)/H4008CEGeneral Electric Co. · 1987
- 1 generation backK953752 RT55 Diagnostic Ultrasound SystemGeneral Electric Co. · 1996
- This deviceK012560 GE Logiq A100 MP, Model 2272413General Electric Co. · 2001
- Descendant · cites it directly · 667 of its ownK014206 LogiqbookGeneral Electric Co. · 2002 · Recalled
- Descendant · 2 generations on · 666 of its ownK032477 GE Logiq BookGeneral Electric Co. · 2003
- Descendant · 2 generations on · 665 of its ownK050126 GE Logiq TwinGeneral Electric Co. · 2005
- Descendant · 3 generations on · 664 of its ownK072797 GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE…General Electric Co. · 2007
- Descendant · 4 generations on · 605 of its ownK091164 GE Venue 40, Model 5324338Ge Medical Systems China Co., Ltd. · 2009
Showing 5 of 668 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 668 · See all- K014206LogiqbookGeneral Electric Co. · 2002 · cites it directly667descendants
- K032477GE Logiq BookGeneral Electric Co. · 2003 · 2 generations on666descendants
- K050126GE Logiq TwinGeneral Electric Co. · 2005 · 2 generations on665descendants
- K072797GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…General Electric Co. · 2007 · 3 generations on664descendants
- K091164GE Venue 40, Model 5324338Ge Medical Systems China Co., Ltd. · 2009 · 4 generations on605descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863700 | RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE | General Electric Co. | 1987 | — |
| −1 | K953752 | RT55 Diagnostic Ultrasound System | General Electric Co. | 1996 | — |
| 0 (this device) | K012560 | GE Logiq A100 MP, Model 2272413 | General Electric Co. | 2001 | — |
| +1 | K014206 | Logiqbook | General Electric Co. | 2002 | 1 |
| +2 | K032477 | GE Logiq Book | General Electric Co. | 2003 | — |
| +2 | K050126 | GE Logiq Twin | General Electric Co. | 2005 | — |
| +3 | K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E… | General Electric Co. | 2007 | — |
| +4 | K091164 | GE Venue 40, Model 5324338 | Ge Medical Systems China Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 13 | 0 |
| 2012 | 16 | 0 |
| 2013 | 20 | 0 |
| 2014 | 29 | 0 |
| 2015 | 39 | 0 |
| 2016 | 42 | 0 |
| 2017 | 64 | 0 |
| 2018 | 49 | 0 |
| 2019 | 37 | 0 |
| 2020 | 57 | 0 |
| 2021 | 45 | 0 |
| 2022 | 46 | 0 |
| 2023 | 38 | 0 |
| 2024 | 50 | 0 |
| 2025 | 58 | 2 |
| 2026 | 43 | 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.
2 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? (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 |
|---|---|---|---|
| * | K953752 | RT55 Diagnostic Ultrasound SystemSummary page 1…OGIQ 100 PRO Diagnostic Uitrasound System Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO 3. Marketed Device: GE LOGIQ o100 diagnostic ultrasound system: K953752, currently in commercial distribution. 4. Device Description: The GE LOGIQ 100 PRO is a portable general purpose diagnostic ultr… | 1996 |
What descends from it? (668)
See all 6681 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014206 | Logiqbook | 2002 | 667 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 9.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K014206 (General Electric Co., 2002) has gone furthest, with 667 descendants of its own.
- 1 other device also cites its predicate K953752.
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 device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult & pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Transrectal (TR); and Transvaginal (TV) applications.
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/K012560 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012560: GE Logiq A100 MP, Model 2272413.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012560
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026