# K953752: RT55 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Mar 15, 1996 after 218 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K863700 (1987). 1 ancestor in all.
669 later devices descend from it; 2 cite it directly.
2 of 671 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863700: RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE, General Electric Co. (1987). 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”.

## Most influential descendants
- K012560: GE Logiq A100 MP, Model 2272413 (2001), 668 descendants of its own
- K014206: Logiqbook (2002), 667 descendants of its own
- K032477: GE Logiq Book (2003), 666 descendants of its own
- K050126: GE Logiq Twin (2005), 665 descendants of its own
- K072797: GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact Ultrasound (2007), 664 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K953752
Methodology: https://510kreport.com/methodology