Cleared Traditional

K011604 - PROSTATE SPECTROSCOPY AND IMAGING EXAM ...

K011604 is an FDA 510(k) clearance for PROSTATE SPECTROSCOPY AND IMAGING EXAM ..., manufactured by Ge Medical Systems, Inc.. The device is a Class 2 Radiology device with product code LNI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K011604 · Ge Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
90d
Days
Class 2
Risk

K011604 is an FDA 510(k) clearance for the PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI. Classified as System, Nuclear Magnetic Resonance Spectroscopic (product code LNI), Class II - Special Controls.

Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on August 22, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ge Medical Systems, Inc. devices

FDA 510(k) Submission Details - K011604

510(k) Number K011604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2001
Decision Date August 22, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNI Device Classification - Class 2, Special Controls

Product Code LNI System, Nuclear Magnetic Resonance Spectroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LNI System, Nuclear Magnetic Resonance Spectroscopic

All 9
Devices cleared under the same product code (LNI) and FDA review panel - the closest regulatory comparables to K011604.
OASIS MRI SYSTEM
K093044 · Hitachi Medical Systems America, Inc. · Mar 2010
ECHELON SPECTROSCOPY PACKAGE
K071506 · Hitachi Medical Systems America, Inc. · Jun 2007
EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
K010129 · Toshiba America Medical Systems, In.C · Apr 2001
MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
K003575 · GE Medical Systems · Jan 2001
MR SPECTROSCOPY PACKAGE
K991568 · Philips Medical Systems (Cleveland), Inc. · Jul 1999
SAGE 7
K984167 · GE Medical Systems · Jan 1999