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510(k) K231360

Ambra PACS by Dicom Grid Dba Ambra Health — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2023
Date Received
May 10, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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