# K983342: MR Guided Procedures (MRGP) Basic Package

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Dec 21, 1998 after 89 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931544 (1993). 7 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955389: MR Guided Procedures Package/Magnetom Open System, Siemens Medical Solutions USA, Inc. (1996) Summary page 3.
- K974844: Outlook System Enhancement Package, Philips Medical Systems (Cleveland), Inc. (1998) Summary page 3.

## Most influential descendants
- K022007: Liberty 5000 Breast Coil with Disposable Biopsy Plates (2002), 2 descendants of its own
- K050728: Open Breast Coil (Obc) with Biopsy Plates (2005), 0 descendants of its own
- K033353: Modification to Liberty 5000 Breast Coil with Disposable Biopsy Plates (2003), 0 descendants of its own
- K991943: MRGP Optical Tracking Unit (1999), 0 descendants of its own

## Indications for use
The Outlook system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The MRGP Basic Package is designed to support and guide diagnostic interventional procedures, such as needle biopsies and drainages.

Source page: https://510kreport.com/device/K983342
Methodology: https://510kreport.com/methodology