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Virgo MRI System

by Millennium Technology Services

510(k) K990153

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990153 Date8 Oct 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Virgo MRI System is a Nuclear Magnetic Resonance Imaging device (product code LNH), classified as a Class II medical system. It utilizes a 0.35 Tesla C-shaped permanent magnet to acquire hydrogen-1 proton imaging and spectroscopy data, supported by a host computer, gradient subsystem, and various RF coils (including head, body/spine, and solenoid coils).

Operated by trained personnel in clinical settings, the device is designed for MRI examinations and spectroscopy. Supplied as a reusable system, it requires compliance with MRI safety protocols and is regulated under FDA 510(k) clearance (K990153) with a decision date of October 8, 1999. The system is intended for use in radiology departments and adheres to regulatory standards for nuclear magnetic resonance imaging systems.