FDA 510(k) clearance · back to tracker

RS85 Diagnostic Ultrasound System

Samsung Medison Co., Ltd. cleared K240516 on 2024-06-12, decision: substantially equivalent

K-number

K240516

Sponsor

Samsung Medison Co., Ltd.

Device

RS85 Diagnostic Ultrasound System

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-06-12

Product code

IYN

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1550

Official FDA record

Open K240516on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K240516 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.