MODIFICATION TO: ECAT LSO PET/CT SCANNER— 510(k) K013504

Name: FDA 510(k) clearance K013504
Creator: U.S. Food and Drug Administration
Published: 2001-10-31

Substantially Equivalent

Cti Pet Systems, Inc.

FDA 510(k) clearance K013504 for MODIFICATION TO: ECAT LSO PET/CT SCANNER, Substantially Equivalent on 2001-10-31. 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: 2001-10-22
Decision date: 2001-10-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPS

view all

K261305 — MICSI-PET2026-09-11
K261427 — uMI Panvivo (uMI Panvivo M)2026-07-28
K261315 — Symbia Pro.specta Q3 (11364751) +3 more2026-05-21
K260524 — uMI Panvivo (5 models)2026-04-03
K253564 — uMI Panvivo (4 models)2026-02-13

More clearances from Cti Pet Systems, Inc.

view all

K050509 — LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I2005-03-25
K042467 — LSO PET/CT HIREZ 642004-10-01
K040933 — ECAT HRRT2004-06-07
K033431 — LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ2003-11-20
K023768 — ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 162002-11-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.