Cleared Traditional

K990153 - VIRGO MRI SYSTEM

K990153 is an FDA 510(k) clearance for VIRGO MRI SYSTEM, manufactured by Millennium Technology Services. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K990153 · Millennium Technology Services · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
262d
Days
Class 2
Risk

K990153 is an FDA 510(k) clearance for the VIRGO MRI SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Millennium Technology Services (Pleasant Hill, US). The FDA issued a Cleared decision on October 8, 1999 after a review of 262 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 Millennium Technology Services devices

FDA 510(k) Submission Details - K990153

510(k) Number K990153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1999
Decision Date October 08, 1999
Days to Decision 262 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
155d slower than avg
Panel avg: 107d · This submission: 262d
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 961
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K990153.
SIGNA HFO/I MAGNETIC RESONANCE SYSTEM
K992746 · Ge Medical Systems, Inc. · Nov 1999
INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
K990826 · Siemens Medical Solutions USA, Inc. · Nov 1999
PHILIPS GYROSCAN INTERA (*)
K992533 · Philips Medical Systems North America, Inc. · Oct 1999
PREFERENCE TREATMENT SYSTEM
K983793 · Northwest Medical Physics Equipment, Inc. · Oct 1999
STEPPING KINEMATIC IMAGING PLATFORM (SKIP)
K992892 · Magnetic Moments, LLC · Sep 1999
PHILIPS EASYVISION WORKSTATION:
K990335 · Philips Medical Systems North America, Inc. · Sep 1999