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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K243077
Device Name Affirm 800
Applicant
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
125 Cremona Dr.
Suite 110
Goleta,  CA  93117
Applicant Contact Lu Ju
Correspondent
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
125 Cremona Dr.
Suite 110
Goleta,  CA  93117
Correspondent Contact Lu Ju
Regulation Number892.1600
Classification Product Code
IZI  
Date Received09/30/2024
Decision Date 06/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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