510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K953582Substantially Equivalent

Hfx350, 30Kw, 300Ma, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray Generator

Varian Canada, Inc., Canada L7g 2j4, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953582 is the FDA 510(k) clearance record for HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR, a class I device, cleared for Varian Canada, Inc. on under FDA product code IZO (Generator, High-Voltage, X-Ray, Diagnostic). FDA records list 7 510(k) clearances for Varian Canada, Inc., from to . As of , FDA records show no recalls naming K953582.

Clearance record

Decision date
Received
(56 days to decision)
Product code
IZO Generator, High-Voltage, X-Ray, Diagnostic
Regulation
21 CFR 892.1700
Device class
Class I
Review panel
Radiology
Applicant
Varian Canada, Inc. 45 River Dr., Canada L7g 2j4, CA
510(k) summary
Statement
Third party review
No

Clearances, product code IZO

Trailing 12 months

FDA records hold no clearances under product code IZO in the trailing twelve months.

FDA records show no clearances under product code IZO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IZO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260