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510(k) K210957

Kubec Xpert 80 Radiography System by Kub Technologies, Inc. — Product Code MWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2021
Date Received
March 30, 2021
Clearance Type
Special
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 Kub Technologies, Inc.

  • K210955 — Kubtec Mozart Supra (XPERT 84) Radiography System (September 20, 2021)
  • K210956 — Kubtec Mozart (XPERT42) (August 31, 2021)
  • K200756 — Kubtec Mozart Supra (June 12, 2020)
  • K183624 — Kubtec Mozart (Xpert42) (June 20, 2019)
  • K151221 — Kubtec DIGIVIEW 395 (June 23, 2015)
  • K141539 — KUBTEC X250 (October 29, 2014)
  • K103348 — DIGIVIEW 250 (October 20, 2011)
  • K083510 — KUBTEC XPERT 20 (January 8, 2009)
  • K071233 — XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM (June 20, 2007)

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)
  • 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)
  • K183624 — Kubtec Mozart (Xpert42) (June 20, 2019)