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FDA 510(k)

MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001

K-Number: K051494 · 2005-09-21

ApplicantCr Tech, Ltd.
Decision Date2005-09-21
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001 is the device name listed in this FDA 510(k) record. The listed applicant is Cr Tech, Ltd.. It received FDA 510(k) clearance on 2005-09-21 under 510(k) number K051494. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001?

MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001 is a medical device that received FDA 510(k) clearance on 2005-09-21. The listed applicant is Cr Tech, Ltd.. The 510(k) number is K051494.

When did MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001 receive FDA 510(k) clearance?

MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001 received FDA 510(k) clearance on 2005-09-21, under 510(k) number K051494.

Who is the listed applicant for MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001?

The FDA 510(k) record lists Cr Tech, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001?

The FDA product code for MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001 is MQB.

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Related Devices (Code: MQB)

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.

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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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