510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K970303Substantially Equivalent

Saturne Multileaf Collimator

General Electric Co., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970303 is the FDA 510(k) clearance record for SATURNE MULTILEAF COLLIMATOR, a class II device, cleared for General Electric Co. on under FDA product code IXI (Block, Beam-Shaping, Radiation Therapy). FDA records list 256 510(k) clearances for General Electric Co., from to . As of , FDA records show no recalls naming K970303.

Clearance record

Decision date
Received
(88 days to decision)
Product code
IXI Block, Beam-Shaping, Radiation Therapy
Regulation
21 CFR 892.5710
Device class
Class II
Review panel
Radiology
Applicant
General Electric Co. P.O. Box 414, Milwaukee WI
510(k) summary
Summary
Third party review
No

Clearances, product code IXI

Trailing 12 months
1 clearance under product code IXI in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IXI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260