# K921653: Vectra Magnetic Resonance System

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Dec 24, 1992 after 261 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0618-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Source page: https://510kreport.com/device/K921653
Methodology: https://510kreport.com/methodology