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510(k) K183624

Kubtec Mozart (Xpert42) by Kub Technologies, Inc. — Product Code MWP

K183624 is an FDA 510(k) premarket notification submitted by Kub Technologies, Inc. for the device "Kubtec Mozart (Xpert42)". The FDA issued a decision of Substantially Equivalent on June 20, 2019. The device falls under product code MWP (Cabinet, X-Ray System), a Class II device regulated under 21 CFR 892.1680. Kub Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2019
Date Received
December 26, 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

Other clearances by Kub Technologies, Inc.

  • K210955 — Kubtec Mozart Supra (XPERT 84) Radiography System (September 20, 2021)
  • K210957 — Kubec Xpert 80 Radiography System (August 31, 2021)
  • K210956 — Kubtec Mozart (XPERT42) (August 31, 2021)
  • K200756 — Kubtec Mozart Supra (June 12, 2020)
  • 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)
  • K210957 — Kubec Xpert 80 Radiography System (August 31, 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)

FDA data resources