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510(k) K183474

Carestream DRX-1 System with DRX Core Detectors by Carestream Health, Inc. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2019
Date Received
December 17, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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Other clearances for product code MQB

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