# K093689: 1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for Siemans

- Pathway: 510(k) (Traditional)
- Applicant: Mr Medical Solutions, LLC
- Decided: Aug 31, 2010 after 274 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: 4 generations back to K892235 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023596: Medrad 8-Receiver Phased Array Neurovascular Coil, Medrad, Inc. (2002) Summary page 1.

## Indications for use
The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil intended to be used with 1.5T Siemens superconducting MRI scanners. The coil is intended to facilitate complete MR imaging of the intracranial/extracranial neurovasculature and skull base. The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil and is indicated for use only under the supervision of a physician or certified MR technologist who is trained in the field of Diagnostic Magnetic Resonance Imaging.

Source page: https://510kreport.com/device/K093689
Methodology: https://510kreport.com/methodology