# K990153: Virgo Mri System

- Pathway: 510(k) (Traditional)
- Applicant: Millennium Technology Services
- Decided: Oct 8, 1999 after 262 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961876 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961876: AIRIS, Hitachi Medical Systems America, Inc. (1996) Summary page 2.
- K974212: Airis II, Hitachi Medical Systems America, Inc. (1998) Summary page 2.
- K980691: Airis Magnetic Resonance Diagnostic Device, Hitachi Medical Systems America, Inc. (1998) Summary page 2.

## Indications for use
Non-invasive, non-ionizing diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities. Diagnostic Image capabilities include: Sagittal section images Cross section & curved cross section images Transverse section images Coronal section images 2D Fast Spin Echo 2D Inversion Recovery 2D Fast Inversion Recovery 2D Dual Slice Acquisition 2D/3D Spin Echo 2D/3D Gradient Echo 2D/3D Gradient Echo w/ Rephasing 2D/3D Steady State Acquisition w/ rewind Gradient Echo (SARGE) MR Angiography Image Processing MR Angiography - Half Echo/High Resolution High Definition 2D/T1/T2 Weighted Imaging T1/T2 Proton Density Measurements

Source page: https://510kreport.com/device/K990153
Methodology: https://510kreport.com/methodology