# K151663: RS80A Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Aug 12, 2015 after 54 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: 21 generations back to K924432 (1993). 200 ancestors in all.
96 later devices descend from it; 7 cite it directly.
0 of 297 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141620: RS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2014) Summary page 4.
- K150478: A35 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2015) Summary page 19.
- K143089: WS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2014) Summary page 18.
- K130803: Ugeo H70C Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2013) Summary page 22.
- K142466: UGEO PT60A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2014) Summary page 23.
- K142160: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2014) Summary page 27.
- K132274: Aixplorer, Supersonic Imagine (2013) Summary page 27.
- K131164: Acuson, Siemens Medical Solutions USA, Inc. (2013) Summary page 27.
- K130881: Acuson S2000 and S3000, Siemens Medical Solutions USA, Inc. (2013) Summary page 27.
- K021966: Q Lab Software, Advanced Technology Laboratories, Inc. (2002) Summary page 27.

## Most influential descendants
- K152962: HS70A Diagnostic Ultrasound System (2015), 90 descendants of its own
- K153529: WS80A Diagnostic Ultrasound System (2016), 89 descendants of its own
- K153408: HM70A Diagnostic Ultrasound System (2015), 65 descendants of its own
- K162094: RS80A Diagnostic Ultrasound System (2016), 64 descendants of its own
- K153539: RS80A Diagnostic Ultrasound System (2016), 59 descendants of its own

## Indications for use
The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Source page: https://510kreport.com/device/K151663
Methodology: https://510kreport.com/methodology