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510(k) K213691

Solas OR by Cirdan Imaging, Ltd. — Product Code MWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2021
Date Received
November 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Cabinet, X-Ray System
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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