# K895794: GE MR Max System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Nov 17, 1989 after 50 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- 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
- K954353: Magnetic Resonance Diagnostic Accessory (1996), 0 descendants of its own

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0619-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Source page: https://510kreport.com/device/K895794
Methodology: https://510kreport.com/methodology