SubtlePET— 510(k) K211964

Substantially Equivalent

Subtle Medical, Inc.

FDA 510(k) clearance K211964 for SubtlePET, Substantially Equivalent on 2021-09-28. Applicant: Subtle Medical, Inc..

Clearance details

Applicant: Subtle Medical, Inc.
Product code: Code KPS
Advisory panel: Radiology
Date received: 2021-06-24
Decision date: 2021-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

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