510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K003573Substantially Equivalent

Diffusion Tensor Imaging Option

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

K003573 is the FDA 510(k) clearance record for DIFFUSION TENSOR IMAGING OPTION, a class II device, cleared for Ge Medical Systems, Inc. on under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K003573.

Clearance record

Decision date
Received
(64 days to decision)
Product code
LNH System, Nuclear Magnetic Resonance Imaging
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Ge Medical Systems, Inc. P.O. Box 414, Milwaukee WI
510(k) summary
Summary
Third party review
No

Clearances, product code LNH

Trailing 12 months
27 clearances under product code LNH in the twelve months to November 2026, March 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code LNH, trailing twelve months
MonthClearances
December 20253
January 20261
February 20264
March 20266
April 20261
May 20261
June 20260
July 20262
August 20263
September 20263
October 20263
November 20260