Cleared Traditional

K002997 - FIESTA IMAGING OPTION

K002997 is an FDA 510(k) clearance for FIESTA IMAGING OPTION, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K002997 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
197d
Days
Class 2
Risk

K002997 is an FDA 510(k) clearance for the FIESTA IMAGING OPTION. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on April 11, 2001 after a review of 197 days - an extended review cycle.

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 devices

FDA 510(k) Submission Details - K002997

510(k) Number K002997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2000
Decision Date April 11, 2001
Days to Decision 197 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
90d slower than avg
Panel avg: 107d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 840
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K002997.
INFINION ENHANCEMENT PACKAGE
K011296 · Philips Medical Systems (Cleveland), Inc. · Jul 2001
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
K010773 · Siemens Medical Solutions USA, Inc. · May 2001
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
K010691 · Philips Medical Systems (Cleveland), Inc. · May 2001
BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160
K010570 · Mri Devices Corp. · Apr 2001
IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM
K003899 · Mri Devices Corp. · Mar 2001
FUNCTIONAL BRAIN MAPPING OPTION FOR MRI
K003947 · GE Medical Systems · Mar 2001