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FDA 510(k)

LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I

K-Number: K050509 · 2005-03-25

Decision Date2005-03-25
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I is the device name listed in this FDA 510(k) record. The listed applicant is Cti Pet Systems, Inc.. It received FDA 510(k) clearance on 2005-03-25 under 510(k) number K050509. 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 LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I?

LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I is a medical device that received FDA 510(k) clearance on 2005-03-25. The listed applicant is Cti Pet Systems, Inc.. The 510(k) number is K050509.

When did LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I receive FDA 510(k) clearance?

LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I received FDA 510(k) clearance on 2005-03-25, under 510(k) number K050509.

Who is the listed applicant for LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I?

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

What is the FDA product code for LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I?

The FDA product code for LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I 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.

Other records listing Cti Pet Systems, 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.

View all 19 devices →

Related Devices (Code: KPS)

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.

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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