# K960527: Logiq 1000 Diagnostic Ultrsound System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Sep 8, 1997 after 580 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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 K930768 (1994). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930768: Orion Diagnostic Ultrasound System, GE Medical Systems (1994) Summary page 1.

## Most influential descendants
- K990226: GE LOGIQ700 Diagnostic Ultrasound System with B-Flow (1999), 2 descendants of its own
- K993365: GE Logiq 700 with Harmonic Imaging Modification (1999), 0 descendants of its own
- K993364: GE Logiq 700 with Coded Excitation Modification (1999), 0 descendants of its own

## Indications for use
The modified GE LOGIQ 700 is a general purpose ultrasound imaging system intended for use by or under the direction of a qualified physician for Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and urological, Musculoskeletal, Abdominal, Pediatric, Small Organ including breast, testes and thyroid, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Trans-vaginal, and Peripheral vessel.

Source page: https://510kreport.com/device/K960527
Methodology: https://510kreport.com/methodology