510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K990153Substantially Equivalent

Virgo MRI System

Millennium Technology Services, Pleasant Hill CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990153 is the FDA 510(k) clearance record for VIRGO MRI SYSTEM, a class II device, cleared for Millennium Technology Services on under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging). FDA records list one 510(k) clearance for Millennium Technology Services. As of , FDA records show no recalls naming K990153.

Clearance record

Decision date
Received
(262 days to decision)
Product code
LNH System, Nuclear Magnetic Resonance Imaging
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Millennium Technology Services 200 Gregory Ln., #C-100, Pleasant Hill CA
510(k) summary
Summary
Third party review
No

Clearances, product code LNH

Trailing 12 months
28 clearances under product code LNH in the twelve months to October 2026, March 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code LNH, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20264
March 20266
April 20261
May 20261
June 20260
July 20262
August 20263
September 20263
October 20263