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
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K081028Substantially Equivalent

Signa 3.0T Mr750 System

GE Healthcare, Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081028 is the FDA 510(k) clearance record for SIGNA 3.0T MR750 SYSTEM, a class II device, cleared for Ge Medical Systems, LLC 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 11 recalls naming K081028.

Clearance record

Decision date
Received
(14 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, LLC 3200 N Grandview Blvd., Waukesha WI
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code LNH

Trailing 12 months
26 clearances under product code LNH in the twelve months to October 2026, March 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code LNH, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20264
March 20266
April 20261
May 20261
June 20260
July 20262
August 20263
September 20263
October 20261