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FDA 510(k)

CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE

K-Number: K111373 · 2011-08-23

ApplicantCircle Cardiovascular Imaging, Inc.
Decision Date2011-08-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Circle Cardiovascular Imaging, Inc.. It received FDA 510(k) clearance on 2011-08-23 under 510(k) number K111373. 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 CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE?

CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE is a medical device that received FDA 510(k) clearance on 2011-08-23. The listed applicant is Circle Cardiovascular Imaging, Inc.. The 510(k) number is K111373.

When did CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE receive FDA 510(k) clearance?

CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE received FDA 510(k) clearance on 2011-08-23, under 510(k) number K111373.

Who is the listed applicant for CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE?

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

What is the FDA product code for CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE?

The FDA product code for CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE is LLZ.

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Related Devices (Code: LLZ)

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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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