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FDA 510(k)

CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING

K-Number: K083446 · 2009-03-31

ApplicantZiosoft, Inc.
Decision Date2009-03-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING is the device name listed in this FDA 510(k) record. The listed applicant is Ziosoft, Inc.. It received FDA 510(k) clearance on 2009-03-31 under 510(k) number K083446. 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 CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING?

CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING is a medical device that received FDA 510(k) clearance on 2009-03-31. The listed applicant is Ziosoft, Inc.. The 510(k) number is K083446.

When did CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING receive FDA 510(k) clearance?

CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING received FDA 510(k) clearance on 2009-03-31, under 510(k) number K083446.

Who is the listed applicant for CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING?

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

What is the FDA product code for CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING?

The FDA product code for CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING is LLZ.

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Other records listing Ziosoft, Inc. as applicant

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.

K200315Ziostation2K181892Ziostation2K091262MR CARDIAC FUNCTION ANALYSISK083084CT BRAIN PERFUSION FOR ZIOSTATIONK070205ZIOSTATION

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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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