WRDensity by Whiterabbit.ai— 510(k) K202013

Name: FDA 510(k) clearance K202013
Creator: U.S. Food and Drug Administration
Published: 2020-10-30

Substantially Equivalent

Whiterabbit.Ai, Inc.

FDA 510(k) clearance K202013 for WRDensity by Whiterabbit.ai, Substantially Equivalent on 2020-10-30. Applicant: Whiterabbit.Ai, Inc.. Device class: 2.

Clearance details

Applicant: Whiterabbit.Ai, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2020-07-21
Decision date: 2020-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, 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.