# K160343: SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Beijing East Whale Imaging Technology Co., Ltd.
- Decided: Apr 7, 2016 after 59 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: 7 generations back to K000695 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102388: Vivid I Diagnostic Ultrasound System, Ge Medical System Israel, Ltd. (2010) Summary page 11.

## Indications for use
The Portable Ultrasound Diagnostic Scanner is intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdomen; Small Parts; Obstetrics; Gynecology; Cardiology; Peripheral Vessels; Urology; Pediatrics; Neonate; Trans-cranial; Musculoskeletal; Fetal; Intra-operative; Transvaginal.

Source page: https://510kreport.com/device/K160343
Methodology: https://510kreport.com/methodology