# K962927: IN-Room MRC/ Magnetom Vision and Impact Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 25, 1996 after 58 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) In-Room MRC commercially available for the MAGNETOM OPEN system: named in the summary without a submission number

## Most influential descendants
- K984280: Airis II Magnetic Resonance Diagnostic Device,Interventional MR Package (1999), 1 descendant of its own
- K053309: Altaire Interventional MR Package (2006), 0 descendants of its own

## Indications for use
The new In-Room MRC is intended to facilitate conventional procedures. The new operating console allows the system operator to control and monitor main system functions irside the RF-cabin.

Source page: https://510kreport.com/device/K962927
Methodology: https://510kreport.com/methodology