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510(k) K183142

PathVisionXL by Faxitron Bioptics, LLC — Product Code MWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2019
Date Received
November 13, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cabinet, X-Ray System
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K122428 — FAXITRON SPECIEN RADIOGRAPHY SYSTEM (September 25, 2012)

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