510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K894142Substantially Equivalent

Ultranet-S Collimator

GE Healthcare, Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894142 is the FDA 510(k) clearance record for ULTRANET-S COLLIMATOR, a class II device, cleared for GE Medical Systems on under FDA product code IZW (Collimator, Automatic, Radiographic). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K894142.

Clearance record

Decision date
Received
(146 days to decision)
Product code
IZW Collimator, Automatic, Radiographic
Regulation
21 CFR 892.1610
Device class
Class II
Review panel
Radiology
Applicant
GE Medical Systems P.O. Box 414, Milwaukee WI
Third party review
No

Clearances, product code IZW

Trailing 12 months

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

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