Saige-Density— 510(k) K222275

Substantially Equivalent

DeepHealth, Inc.

FDA 510(k) clearance K222275 for Saige-Density, Substantially Equivalent on 2022-12-16. Applicant: DeepHealth, Inc.. Device class: 2.

Clearance details

Applicant
DeepHealth, Inc.
Product code
Code QIH
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cambridge, MA, US
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