FDA 510(k)

CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2

K-Number: K053062 · 2006-01-06

Decision Date2006-01-06

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiarc , Ltd.. It received FDA 510(k) clearance on 2006-01-06 under 510(k) number K053062. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2?

CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 is a medical device that received FDA 510(k) clearance on 2006-01-06. The listed applicant is Cardiarc , Ltd.. The 510(k) number is K053062.

When did CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 receive FDA 510(k) clearance?

CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 received FDA 510(k) clearance on 2006-01-06, under 510(k) number K053062.

Who is the listed applicant for CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2?

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

What is the FDA product code for CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2?

The FDA product code for CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 is KPS.

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Official Source

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