# K240516: RS85 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Jun 12, 2024 after 110 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: 33 generations back to K924432 (1993). 298 ancestors in all.
No later device cites it as a predicate yet.
0 of 299 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221117: RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2022) Summary page 4.

## Indications for use
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans rectal, Trans vaginal, Muscular Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans esophageal(Cardiac) and Peripheral vessel. It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients. Modes of Operation: 20 mode, M mode, Color Doppler mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TOI) mode, Tissue Doppler Wave (TOW) mode, Power Doppler (PD) mode, ElastoScan™ Mode, Multi Image mode(Dual, Quad), Combined modes, 30 /40 mode.

Source page: https://510kreport.com/device/K240516
Methodology: https://510kreport.com/methodology