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510(k) K243077

Affirm 800 by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2025
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

Other clearances by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)

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