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FDA 510(k)

CoreLite X-Ray Specimen Cabinet

K-Number: K193317 · 2019-12-13

ApplicantCirdan Imaging Limited
Decision Date2019-12-13
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CoreLite X-Ray Specimen Cabinet is a medical device manufactured by Cirdan Imaging Limited. It received FDA 510(k) clearance on 2019-12-13 under approval number K193317. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoreLite X-Ray Specimen Cabinet?

CoreLite X-Ray Specimen Cabinet is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Cirdan Imaging Limited. The 510(k) number is K193317.

When was CoreLite X-Ray Specimen Cabinet approved by the FDA?

CoreLite X-Ray Specimen Cabinet received FDA 510(k) clearance on 2019-12-13, under approval number K193317.

What company makes CoreLite X-Ray Specimen Cabinet?

CoreLite X-Ray Specimen Cabinet is manufactured by Cirdan Imaging Limited.

What is the FDA product code for CoreLite X-Ray Specimen Cabinet?

The FDA product code for CoreLite X-Ray Specimen Cabinet is MWP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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