# K013528: Crystal 5000 Phases Array TMJ Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Dec 13, 2001 after 51 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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: 1 generation back to K944773 (1995). 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)
- K944773: Model 405GE-64: Phased Array TMJ Coil, Medical Advances, Inc. (1995) Summary page 2.
- K001210: HI-Res 9000 Phased Array Carotid Coil, Usa Instruments, Inc. (2000) Summary page 2.

## Indications for use
The Crystal 5000 Phased Array TMJ Coil is designed to provide Magnetic Resonance Images of the temporo-mandibular joint. The Crystal 5000 Phased Array TMJ Coil is designed for use with the Marconi Medical Systems' Proview 0.23Tesla scanner. Anatomic Regions: Temporo-mandibular Joint Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Marconi Medical Systems Proview 0.23Tesla system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, 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.

Source page: https://510kreport.com/device/K013528
Methodology: https://510kreport.com/methodology