510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K974256Substantially Equivalent

Ecat Pet Scanners

Siemens Medical Solutions USA, Inc., Knoxville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974256 is the FDA 510(k) clearance record for ECAT PET SCANNERS, a class II device, cleared for Cti Pet Systems, Inc. on under FDA product code KPS (System, Tomography, Computed, Emission). FDA records list 829 510(k) clearances for SIEMENS MEDICAL SOLUTIONS USA, INC., from to . As of , FDA records show no recalls naming K974256.

Clearance record

Decision date
Received
(104 days to decision)
Product code
KPS System, Tomography, Computed, Emission
Regulation
21 CFR 892.1200
Device class
Class II
Review panel
Radiology
Applicant
Cti Pet Systems, Inc. 810 Innovation Dr., Knoxville TN
510(k) summary
Statement
Third party review
No

Clearances, product code KPS

Trailing 12 months
8 clearances under product code KPS in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPS, trailing twelve months
MonthClearances
December 20252
January 20261
February 20261
March 20260
April 20261
May 20261
June 20260
July 20261
August 20260
September 20261
October 20260
November 20260