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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K250290
Device Name SurgiTwin
Applicant
Twinsight
Biopolis
5 Ave. Du Grand Sablon
La Tronche,  FR 38700
Applicant Contact Meghan McFadden
Correspondent
Twinsight
Biopolis
5 Ave. Du Grand Sablon
La Tronche,  FR 38700
Correspondent Contact Meghan McFadden
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
QIH  
Date Received01/31/2025
Decision Date 08/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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