Saige-Dx— 510(k) K220105

Substantially Equivalent

DeepHealth, Inc.

FDA 510(k) clearance K220105 for Saige-Dx, Substantially Equivalent on 2022-05-12. Applicant: DeepHealth, Inc..

Clearance details

Applicant: DeepHealth, Inc.
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2022-01-12
Decision date: 2022-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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