# K153037: Logiq V1/ Logiq V2

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Decided: Jan 4, 2016 after 77 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: 19 generations back to K935595 (1995). 137 ancestors in all.
No later device cites it as a predicate yet.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151028: LOGIQ e, GE Medical Systems Ultrasound and Primary Care Diagnostics (2015) Summary page 7.
- K141768: Logiq V5/Logiq V3, GE Healthcare (2014) Summary page 6.

## Indications for use
The LOGIQ V1 / LOGIQ V2 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; GYN; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Urology; Transrectal; Transvaginal; imaging guidance of interventional procedures (e.g. Nerve Block, Vascular Access, Tissue Biopsy/Fluid Drainage).

Source page: https://510kreport.com/device/K153037
Methodology: https://510kreport.com/methodology