Cleared Traditional

GYROSCAN INTERA 3.0T (K003516) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003516 · Philips Medical Systems North America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
43d
Days
Class 2
Risk

K003516 is an FDA 510(k) clearance for the GYROSCAN INTERA 3.0T. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on December 27, 2000 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Philips Medical Systems North America, Inc. devices

Submission Details

510(k) Number K003516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2000
Decision Date December 27, 2000
Days to Decision 43 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 474
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K003516.
FUNCTIONAL BRAIN MAPPING OPTION FOR MRI
K003947 · GE Medical Systems · Mar 2001
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
K003853 · Philips Medical Systems (Cleveland), Inc. · Feb 2001
MAGNETOM RHAPSODY SYSTEM
K003628 · Siemens Medical Solutions USA, Inc. · Jan 2001
MAGNETIC CONCERTO
K003192 · Siemens Medical Solutions USA, Inc. · Dec 2000
INTERACTIVE REAL TIME SCANNING PACKAGE
K003623 · Siemens Medical Solutions USA, Inc. · Dec 2000
SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
K002611 · GE Medical Systems · Oct 2000