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FDA 510(k)

QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM

K-Number: K850455 · 1985-05-06

ApplicantXre Corp.
Decision Date1985-05-06
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xre Corp.. It received FDA 510(k) clearance on 1985-05-06 under 510(k) number K850455. 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 QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM?

QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM is a medical device that received FDA 510(k) clearance on 1985-05-06. The listed applicant is Xre Corp.. The 510(k) number is K850455.

When did QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM receive FDA 510(k) clearance?

QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM received FDA 510(k) clearance on 1985-05-06, under 510(k) number K850455.

Who is the listed applicant for QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM?

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

What is the FDA product code for QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM?

The FDA product code for QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM 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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