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FDA 510(k)

PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL

K-Number: K092747 · 2009-10-09

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2009-10-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2009-10-09 under 510(k) number K092747. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL?

PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL is a medical device that received FDA 510(k) clearance on 2009-10-09. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K092747.

When did PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL receive FDA 510(k) clearance?

PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL received FDA 510(k) clearance on 2009-10-09, under 510(k) number K092747.

Who is the listed applicant for PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL?

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

What is the FDA product code for PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL?

The FDA product code for PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL is JAK.

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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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