Carestream DRX-1 System with DRX Core Detectors— 510(k) K183474

Substantially Equivalent

Carestream Health, Inc.

FDA 510(k) clearance K183474 for Carestream DRX-1 System with DRX Core Detectors, Substantially Equivalent on 2019-01-16. Applicant: Carestream Health, Inc..

Clearance details

Applicant
Carestream Health, Inc.
Product code
Code MQB
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Rochester, NY, US
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