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510(k) K170786

Faxitron Bioptics Speciemen Radiography System by Faxitron Bioptics, LLC — Product Code MWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2017
Date Received
March 16, 2017
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

Other clearances by Faxitron Bioptics, LLC

  • K183142 — PathVisionXL (March 14, 2019)
  • K173309 — Faxitron VisionCT (May 9, 2018)
  • K153583 — BioVision Plus (April 1, 2016)
  • K122428 — FAXITRON SPECIEN RADIOGRAPHY SYSTEM (September 25, 2012)

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  • K210957 — Kubec Xpert 80 Radiography System (August 31, 2021)
  • K202713 — TrueView 100 Pro (November 18, 2020)
  • K200756 — Kubtec Mozart Supra (June 12, 2020)
  • K192939 — Volumetric Specimen Imager (December 27, 2019)
  • K193317 — CoreLite X-Ray Specimen Cabinet (December 13, 2019)