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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 K213128
Device Name IntraOp VSP Software Device
Applicant
Xironetic, LLC
712 N Broadway Ave
Oklahoma City,  OK  73102
Applicant Contact Christian El Amm
Correspondent
Paladin Medical, Inc
PO Box 560
Stillwater,  MN  55082
Correspondent Contact Elaine Duncan
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/27/2021
Decision Date 10/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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