510(k) · Cleared
ClearedRT55 Diagnostic Ultrasound System
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 Mar 15, 1996 as substantially equivalent to K863700 (General Electric Co., 1987) after a 218-day review. Its family tree reaches back 1 generation to 1987. 2 of the 671 devices in its family, counting itself, have a Class I recall. 669 later devices descend from it.
- Decided
- Mar 15, 1996
- Review
- 218 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K863700 (1987). 669 later devices descend from it, 2 citing it directly. 2 of the 671 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK863700 RT2800(115V)/H4008C and RT2800(220/240V)/H4008CEGeneral Electric Co. · 1987
- This deviceK953752 RT55 Diagnostic Ultrasound SystemGeneral Electric Co. · 1996
- Descendant · cites it directly · 668 of its ownK012560 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
Showing 5 of 669 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 669 · See all- K012560GE Logiq A100 MP, Model 2272413General Electric Co. · 2001 · cites it directly668descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863700 | RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE | General Electric Co. | 1987 | — |
| 0 (this device) | K953752 | RT55 Diagnostic Ultrasound System | General Electric Co. | 1996 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K863700 | RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE Our OCR of the scanned summary read K873700, FDA’s number for Institutional Bili Light (Ibl) (Physician Engineered Products, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GE Medical Systems RT2800 diagnostic ultrasound system”. | 1987 |
What descends from it? (669)
See all 6692 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)
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?
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 RT55 portable ultrasound diagnostic system is intended for use in obstetrics, gynecology and general radiology examinations by a qualified physician to aid in the diagnosis and evaluation of soft tissues by generating two dimensional images, time-motion images and biometric data. The specific intended uses of this system include: abdominal, small parts, pediatric and fetal imaging.
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/K953752 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953752: RT55 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/K953752
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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