# K944331: Model 528GE Series

- Pathway: 510(k) (Traditional)
- Applicant: Medical Advances, Inc.
- Decided: Jan 25, 1995 after 141 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972592: 2T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP (100-6327-0101) (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K944331
Methodology: https://510kreport.com/methodology