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510(k) K213568

DRX-Rise Mobile X-ray System by Carestream Health — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2022
Date Received
November 9, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

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