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510(k) K193317

CoreLite X-Ray Specimen Cabinet by Cirdan Imaging Limited — Product Code MWP

K193317 is an FDA 510(k) premarket notification submitted by Cirdan Imaging Limited for the device "CoreLite X-Ray Specimen Cabinet". The FDA issued a decision of Substantially Equivalent on December 13, 2019. The device falls under product code MWP (Cabinet, X-Ray System), a Class II device regulated under 21 CFR 892.1680.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2019
Date Received
November 29, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Cabinet, X-Ray System
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K230140 — TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-U (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)
  • K183624 — Kubtec Mozart (Xpert42) (June 20, 2019)

FDA data resources