Saige-Dx (3.1.0)— 510(k) K243688

Substantially Equivalent

DeepHealth, Inc.

FDA 510(k) clearance K243688 for Saige-Dx (3.1.0), Substantially Equivalent on 2024-12-19. Applicant: DeepHealth, Inc..

Clearance details

Applicant
DeepHealth, Inc.
Product code
Code QDQ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Somerville, MA, US
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