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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 K213253
Device Name Pixyl.Neuro
Applicant
Pixyl SA
5 Ave. Du Grand Sablon
La Tronche,  FR 38700
Applicant Contact Senan Doyle
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Robert V. Packard
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/30/2021
Decision Date 06/30/2023
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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