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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 the device name listed in this FDA 510(k) record. The listed applicant is Cirdan Imaging Limited. It received FDA 510(k) clearance on 2019-12-13 under 510(k) 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. The listed applicant is Cirdan Imaging Limited. The 510(k) number is K193317.

When did CoreLite X-Ray Specimen Cabinet receive FDA 510(k) clearance?

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

Who is the listed applicant for CoreLite X-Ray Specimen Cabinet?

The FDA 510(k) record lists Cirdan Imaging Limited as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Cirdan Imaging Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213691Solas OR

Related Devices (Code: MWP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)Compai Healthcare (Suzhou) Co.,LtdK230136TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)Compai Healthcare (Suzhou) Co.,LtdK213691Solas ORCirdan Imaging, Ltd.K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.K210956Kubtec Mozart (XPERT42)Kub Technologies, Inc.

Official Source

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