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510(k) K213253

Pixyl.Neuro by Pixyl SA — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2023
Date Received
September 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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