FDA 510(k)

CLARITY PET

K-Number: K032866 · 2003-12-12

Decision Date2003-12-12

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CLARITY PET is the device name listed in this FDA 510(k) record. The listed applicant is Shared P.E.T. Imaging, LLC. It received FDA 510(k) clearance on 2003-12-12 under 510(k) number K032866. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARITY PET?

CLARITY PET is a medical device that received FDA 510(k) clearance on 2003-12-12. The listed applicant is Shared P.E.T. Imaging, LLC. The 510(k) number is K032866.

When did CLARITY PET receive FDA 510(k) clearance?

CLARITY PET received FDA 510(k) clearance on 2003-12-12, under 510(k) number K032866.

Who is the listed applicant for CLARITY PET?

The FDA 510(k) record lists Shared P.E.T. Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLARITY PET?

The FDA product code for CLARITY PET is KPS.

Related Clinical Trials

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.

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Other records listing Shared P.E.T. Imaging, LLC as applicant

K042692CLARITY FUSION

Related Devices (Code: KPS)

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.