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FDA 510(k)

QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)

K-Number: K993763 · 1999-11-26

ApplicantMedis Medical Imaging Systems BV
Decision Date1999-11-26
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) is the device name listed in this FDA 510(k) record. The listed applicant is Medis Medical Imaging Systems BV. It received FDA 510(k) clearance on 1999-11-26 under 510(k) number K993763. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)?

QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) is a medical device that received FDA 510(k) clearance on 1999-11-26. The listed applicant is Medis Medical Imaging Systems BV. The 510(k) number is K993763.

When did QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) receive FDA 510(k) clearance?

QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) received FDA 510(k) clearance on 1999-11-26, under 510(k) number K993763.

Who is the listed applicant for QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)?

The FDA 510(k) record lists Medis Medical Imaging Systems BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)?

The FDA product code for QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) is IZI.

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Related Devices (Code: IZI)

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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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