FractureDetect (FX)— 510(k) K193417

Substantially Equivalent

Imagen Technologies, Inc.

FDA 510(k) clearance K193417 for FractureDetect (FX), Substantially Equivalent on 2020-07-30. Applicant: Imagen Technologies, Inc..

Clearance details

Applicant: Imagen Technologies, Inc.
Product code: Code QBS
Advisory panel: Radiology
Date received: 2019-12-09
Decision date: 2020-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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