# K222257: 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corporation (Business Trade Name: Philips)
- Decided: Aug 23, 2022 after 27 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 K934396 (1993). 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)
- K934396: Quadrature Lower Extremity Coil, Medical Advances, Inc. (1993) Summary page 4.
- K032633: HRK-63-8 Knee Array Coil, Mri Devices Corp. (2003) Summary page 4.

## Indications for use
The 1.5T T/R Quad Extremity Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the lower extremities that can be interpreted by a trained physician. The 1.5T 8CH T/R Knee Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K222257
Methodology: https://510kreport.com/methodology