FDA 510(k)

ECAT LSO PET/CT 16

K-Number: K023518 · 2002-11-08

Decision Date2002-11-08

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ECAT LSO PET/CT 16 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 2002-11-08 under 510(k) number K023518. 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 ECAT LSO PET/CT 16?

ECAT LSO PET/CT 16 is a medical device that received FDA 510(k) clearance on 2002-11-08. The listed applicant is Cti Pet Systems, Inc.. The 510(k) number is K023518.

When did ECAT LSO PET/CT 16 receive FDA 510(k) clearance?

ECAT LSO PET/CT 16 received FDA 510(k) clearance on 2002-11-08, under 510(k) number K023518.

Who is the listed applicant for ECAT LSO PET/CT 16?

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 ECAT LSO PET/CT 16?

The FDA product code for ECAT LSO PET/CT 16 is KPS.

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.

K050509LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I K042467LSO PET/CT HIREZ 64 K040933ECAT HRRT K033431LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ K023768ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 K021633ECAT VISION PET SCANNER, MODELS 3000 & 5000

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Related Devices (Code: KPS)

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.