FDA 510(k) clearance · back to tracker

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System

Samsung Medison Co., Ltd. cleared K242444 on 2024-11-27, decision: substantially equivalent

K-number

K242444

Sponsor

Samsung Medison Co., Ltd.

Device

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-11-27

Product code

IYN

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1550

Official FDA record

Open K242444on 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 K242444 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.