# K112293: HTS Extremity Coil, HTS Surface Coil

- Pathway: 510(k) (Abbreviated)
- Applicant: Time Medical Systems, Inc.
- Decided: Sep 30, 2011 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: 2 generations back to K073457 (2008). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092230: Mona - Orthopedic Mri System, Model TMS-200ORTH-01, Time Medical Limited (2009) Summary page 1.
- K022863: HTS Coil, Jockey Club Mri Engineering Center (2003) Summary page 1.

## Indications for use
HTS Surface Coil is used to image peripheral anatomies, such as, wrist, ankle, Temporo-mandibular Joints (TMJ), Eye, finger and other parts of the body, close to the surface of skin. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System. HTS Extremity Coil is predominantly used for imaging anatomies, such as, knee, ankle, and wrist. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System.

Source page: https://510kreport.com/device/K112293
Methodology: https://510kreport.com/methodology