# K991943: MRGP Optical Tracking Unit

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Aug 23, 1999 after 75 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
Longest line of descent: 5 generations back to K931544 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983342: MR Guided Procedures (MRGP) Basic Package, Philips Medical Systems (Cleveland), Inc. (1998) Summary page 2.
- K990868: Viewpoint Passive Tool Option, Philips Medical Systems (Cleveland), Inc. (1999) Summary page 2.

## 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 Optical Tracking Unit is designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages.

Source page: https://510kreport.com/device/K991943
Methodology: https://510kreport.com/methodology