510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011604Substantially Equivalent

Prostate Spectroscopy and Imaging Exam (Prose) Software Option for MRI

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

K011604 is the FDA 510(k) clearance record for PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI, a class II device, cleared for Ge Medical Systems, Inc. on under FDA product code LNI (System, Nuclear Magnetic Resonance Spectroscopic). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K011604.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LNI System, Nuclear Magnetic Resonance Spectroscopic
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 LNI

Trailing 12 months

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

FDA records show no clearances under product code LNI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LNI, 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