510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K093891Substantially Equivalent

Aquilion One Version 4.6 W/dual Energy Scan System, Model Tsx-301A/2

Toshibamedical Systems Corporation, Tustin CA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093891 is the FDA 510(k) clearance record for AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2, a class II device, cleared for Toshibamedical Systems Corporation on under FDA product code JAK (System, X-Ray, Tomography, Computed). FDA records list 80 510(k) clearances for Toshibamedical Systems Corporation, from to . As of , FDA records show one recall naming K093891.

Clearance record

Decision date
Received
(335 days to decision)
Product code
JAK System, X-Ray, Tomography, Computed
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Toshibamedical Systems Corporation 2441 Michelle Dr., Tustin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAK

Trailing 12 months
21 clearances under product code JAK in the twelve months to October 2026, March 2026 the highest month at 10.
Show the numbers
Monthly 510(k) clearances under FDA product code JAK, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 202610
April 20260
May 20261
June 20262
July 20262
August 20260
September 20264
October 20260