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FDA 510(k)

QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM

K-Number: K892711 · 1989-12-14

ApplicantQuantitative Cardiac Systems (Qcs), Inc.
Decision Date1989-12-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Quantitative Cardiac Systems (Qcs), Inc.. It received FDA 510(k) clearance on 1989-12-14 under 510(k) number K892711. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM?

QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1989-12-14. The listed applicant is Quantitative Cardiac Systems (Qcs), Inc.. The 510(k) number is K892711.

When did QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM receive FDA 510(k) clearance?

QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM received FDA 510(k) clearance on 1989-12-14, under 510(k) number K892711.

Who is the listed applicant for QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM?

The FDA 510(k) record lists Quantitative Cardiac Systems (Qcs), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM?

The FDA product code for QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM is LLZ.

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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.

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