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510(k) K082432

CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM by Bioptics, Inc. — Product Code MWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2008
Date Received
August 22, 2008
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 Bioptics, Inc.

  • K091928 — 10 X 10 VISION (June 16, 2010)
  • K091558 — BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM (July 17, 2009)
  • K052433 — PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM (October 18, 2005)

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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)