# K964752: Kinematic Positioning Devices; C-Spine, Knee,Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Feb 24, 1997 after 89 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: 2 generations back to K924154 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961121: Kinematic Knee Device/Magnetom Open System, Siemens Medical Solutions USA, Inc. (1996) Summary page 2.

## Indications for use
The Picker International Outlook system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, 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 Kinematic Positioning Devices enable the physician to evaluate the anatomy and the functional interactions of the surrounding tissues (ligaments, cartilage, bone, muscle and fat). The Kinematic Positioning Devices are indicated for use in the Cervical Spine, Knee and Shoulder.

Source page: https://510kreport.com/device/K964752
Methodology: https://510kreport.com/methodology