510(k) · Cleared
Recalled · 2004Logiqbook
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 Jan 16, 2002 as substantially equivalent to K953752 (General Electric Co., 1996) and 1 other predicate after a 26-day review. Its family tree reaches back 3 generations to 1987. 2 of the 671 devices in its family, counting itself, have a Class I recall. 667 later devices descend from it. It has been recalled once.
- Decided
- Jan 16, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K863700 (1987). 667 later devices descend from it, 4 citing it directly. 2 of the 671 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK863700 RT2800(115V)/H4008C and RT2800(220/240V)/H4008CEGeneral Electric Co. · 1987
- 2 generations backK953752 RT55 Diagnostic Ultrasound SystemGeneral Electric Co. · 1996
- 1 generation backK012560 GE Logiq A100 MP, Model 2272413General Electric Co. · 2001
- This deviceK014206 LogiqbookGeneral Electric Co. · 2002
- Descendant · cites it directly · 666 of its ownK032477 GE Logiq BookGeneral Electric Co. · 2003
- Descendant · cites it directly · 665 of its ownK050126 GE Logiq TwinGeneral Electric Co. · 2005
- Descendant · 2 generations on · 664 of its ownK072797 GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE…General Electric Co. · 2007
- Descendant · 3 generations on · 605 of its ownK091164 GE Venue 40, Model 5324338Ge Medical Systems China Co., Ltd. · 2009
- Descendant · 3 generations on · 521 of its ownK091374 GE Logiq I/E & Vivid E Compact UltrasoundGe Medical Systems China Co., Ltd. · 2009
Showing 5 of 667 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 667 · See all- K032477GE Logiq BookGeneral Electric Co. · 2003 · cites it directly666descendants
- K050126GE Logiq TwinGeneral Electric Co. · 2005 · cites it directly665descendants
- K072797GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…General Electric Co. · 2007 · 2 generations on664descendants
- K091164GE Venue 40, Model 5324338Ge Medical Systems China Co., Ltd. · 2009 · 3 generations on605descendants
- K091374GE Logiq I/E & Vivid E Compact UltrasoundGe Medical Systems China Co., Ltd. · 2009 · 3 generations on521descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863700 | RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE | General Electric Co. | 1987 | — |
| −2 | K953752 | RT55 Diagnostic Ultrasound System | General Electric Co. | 1996 | — |
| −1 | K012560 | GE Logiq A100 MP, Model 2272413 | General Electric Co. | 2001 | — |
| 0 (this device) | K014206 | Logiqbook | General Electric Co. | 2002 | — |
| +1 | K032477 | GE Logiq Book | General Electric Co. | 2003 | — |
| +1 | K050126 | GE Logiq Twin | General Electric Co. | 2005 | — |
| +2 | K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E… | General Electric Co. | 2007 | — |
| +3 | K091164 | GE Venue 40, Model 5324338 | Ge Medical Systems China Co., Ltd. | 2009 | — |
| +3 | K091374 | GE Logiq I/E & Vivid E Compact Ultrasound | Ge Medical Systems China Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K953752 | RT55 Diagnostic Ultrasound SystemSummary page 1…ing System, 21 CFR 892.1560, 90-1YO Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE LOGIQ 100 Diagnostic Ultrasound System, 510(k) Nos: K953752 and K012560 currently in commercial distribution. 4, Device Description: The GE LOGIQbook is a compact and portable diagnostic u… | 1996 |
| * | K012560 | GE Logiq A100 MP, Model 2272413Summary page 1…21 CFR 892.1560, 90-1YO Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE LOGIQ 100 Diagnostic Ultrasound System, 510(k) Nos: K953752 and K012560 currently in commercial distribution. 4, Device Description: The GE LOGIQbook is a compact and portable diagnostic ultrasound sy… | 2001 |
What descends from it? (667)
See all 6674 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 2, 2004 | Not classified | Z-0387-06 | Other | The Estimated Fetal Weight (EFW) result will be incorrect if the operator fails to perform the 'end exam' or new patient registration step before starting an EFW measurement procedure on the next patient. |
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 15 years and passes through 1 company; a new generation was cleared every 5.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K032477 (General Electric Co., 2003) has gone furthest, with 666 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 and pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Transrectal; and Transvaginal.
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/K014206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014206: Logiqbook.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014206
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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