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510(k) K191884

DR 100s by Agfa N.V. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2019
Date Received
July 15, 2019
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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