LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ— 510(k) K033431

Name: FDA 510(k) clearance K033431
Creator: U.S. Food and Drug Administration
Published: 2003-11-20

Substantially Equivalent

Cti Pet Systems, Inc.

FDA 510(k) clearance K033431 for LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ, Substantially Equivalent on 2003-11-20. Applicant: Cti Pet Systems, Inc.. Device class: 2.

Clearance details

Applicant: Cti Pet Systems, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2003-10-28
Decision date: 2003-11-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

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K040933 — ECAT HRRT2004-06-07
K023768 — ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 162002-11-25
K023518 — ECAT LSO PET/CT 162002-11-08

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