FDA 510(k) K210365, Second Opinion, by Pearl, Inc.
FDA 510(k) K210365, Second Opinion, by Pearl, Inc.
Device Classification Name: Analyzer, Medical Image
510(k) Number: K210365
Device Name: Second Opinion
Applicant: Pearl, Inc.
Regulation Number: 892.207
Classification Product Code: MYN
Date Received: 02/08/2021
Decision Date: 03/04/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
510k Review Panel: Radiology
Total number of pages: 9,542
Fully redacted pages: 5,256
Content pages: 4,286
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