# K955389: MR Guided Procedures Package/Magnetom Open System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 10, 1996 after 199 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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) Magnetom Open: named in the summary without a submission number

## Most influential descendants
- K983342: MR Guided Procedures (MRGP) Basic Package (1998), 4 descendants of its own
- K022007: Liberty 5000 Breast Coil with Disposable Biopsy Plates (2002), 2 descendants of its own
- 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
- K050728: Open Breast Coil (Obc) with Biopsy Plates (2005), 0 descendants of its own

## Indications for use
The MR-guided procedure package is designed to support diagnostic, interventional needle biopsies and drainages.

Source page: https://510kreport.com/device/K955389
Methodology: https://510kreport.com/methodology