# K970901: GE Logiq 500 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Dec 22, 1997 after 286 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 K933202 (1994). 1 ancestor in all.
1,017 later devices descend from it; 4 cite it directly.
3 of 1,019 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933202: Venus Diagnostic Ultrasound System, GE Medical Systems (1994) Summary page 1.
- (no number) Atl Hdi 3000: named in the summary without a submission number

## Most influential descendants
- K991611: GE Logiq 500 (1999), 1,015 descendants of its own
- K040502: Sonoline Ebisu Diagnostic Ultrasound Systems (2004), 930 descendants of its own
- K042833: Sonoline G20 Diagnostic Ultrasound Systems (2004), 928 descendants of its own
- K043016: Sonoline Orchid Diagnostic Ultrasound System (2004), 927 descendants of its own
- K052894: Sonoline G60 S Ultrasound System (2005), 926 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Source page: https://510kreport.com/device/K970901
Methodology: https://510kreport.com/methodology