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FDA 510(k)

CLARITY FUSION

K-Number: K042692 · 2004-10-07

ApplicantShared P.E.T. Imaging, LLC
Decision Date2004-10-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CLARITY FUSION 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 2004-10-07 under 510(k) number K042692. 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 CLARITY FUSION?

CLARITY FUSION is a medical device that received FDA 510(k) clearance on 2004-10-07. The listed applicant is Shared P.E.T. Imaging, LLC. The 510(k) number is K042692.

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

CLARITY FUSION received FDA 510(k) clearance on 2004-10-07, under 510(k) number K042692.

Who is the listed applicant for CLARITY FUSION?

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 FUSION?

The FDA product code for CLARITY FUSION is LLZ.

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

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.

K032866CLARITY PET

Related Devices (Code: LLZ)

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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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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