# K020601: Flexicoil - Malleable Receive-Only Surface Coil

- Pathway: 510(k) (Traditional)
- Applicant: Odin Medical Technologies, Ltd.
- Decided: Apr 24, 2002 after 61 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 K911642 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991243: NORMA 10, Odin Technologies, Ltd. (1999) Summary page 2.
- K003366: Model 545PH Series: Phased Array Musculo-Skeletal Flex Coil, Igc-Medical Advances, Inc. (2000) Summary page 2.

## Indications for use
A magnetic resonance diagnostic device is intended for general diagnostic use to present images, which reflect the spatial distribution and/or magnetic resonance spectra, which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. The FlexiCoil - malleable receive-only surface coil expands the capability of the PoleStar N-10 MR Imaging System. It improves imaging of selected sections of the head and extremities.

Source page: https://510kreport.com/device/K020601
Methodology: https://510kreport.com/methodology