510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894056Substantially Equivalent

Positron Emission Computed Tomograph Set-1400W

Shimadzu Medical Systems, Gardena CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894056 is the FDA 510(k) clearance record for POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W, a class II device, cleared for Shimadzu Medical Systems on under FDA product code KPS (System, Tomography, Computed, Emission). FDA records list 90 510(k) clearances for Shimadzu Medical Systems, from to . As of , FDA records show no recalls naming K894056.

Clearance record

Decision date
Received
(161 days to decision)
Product code
KPS System, Tomography, Computed, Emission
Regulation
21 CFR 892.1200
Device class
Class II
Review panel
Radiology
Applicant
Shimadzu Medical Systems 101 W. Walnut St., Gardena CA
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