ClearRead Xray Pneumothorax— 510(k) K213566

Name: FDA 510(k) clearance K213566
Creator: U.S. Food and Drug Administration
Published: 2022-03-10

Substantially Equivalent

Riverain Technologies, Inc.

FDA 510(k) clearance K213566 for ClearRead Xray Pneumothorax, Substantially Equivalent on 2022-03-10. Applicant: Riverain Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Riverain Technologies, Inc.
Product code: Code QFM
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2021-11-09
Decision date: 2022-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.