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510(k) K052433

PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM by Bioptics, Inc. — Product Code MWP

K052433 is an FDA 510(k) premarket notification submitted by Bioptics, Inc. for the device "PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM". The FDA issued a decision of Substantially Equivalent on October 18, 2005. The device falls under product code MWP (Cabinet, X-Ray System), a Class II device regulated under 21 CFR 892.1680. Bioptics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2005
Date Received
September 6, 2005
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)
  • K082432 — CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM (November 21, 2008)

Other clearances for product code MWP

  • K230140 — TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-U (April 24, 2023)
  • K230136 — TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) (April 24, 2023)
  • K213691 — Solas OR (December 22, 2021)
  • K210955 — Kubtec Mozart Supra (XPERT 84) Radiography System (September 20, 2021)
  • K210956 — Kubtec Mozart (XPERT42) (August 31, 2021)
  • 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)

FDA data resources