Dynamyx Digital Pathology Software— 510(k) K210811

Name: FDA 510(k) clearance K210811
Creator: U.S. Food and Drug Administration
Published: 2022-03-01

Substantially Equivalent

Inspirata, Inc.

FDA 510(k) clearance K210811 for Dynamyx Digital Pathology Software, Substantially Equivalent on 2022-03-01. Applicant: Inspirata, Inc.. Device class: 2.

Clearance details

Applicant: Inspirata, Inc.
Product code: Code QKQ
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2021-03-17
Decision date: 2022-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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