# K163661: P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil

- Pathway: 510(k) (Traditional)
- Applicant: Rapid Biomedical GmbH
- Decided: Mar 21, 2018 after 449 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 K031815 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043147: Achieva Family, Philips Medical Systems North America Co. (2005) Summary page 5.

## Indications for use
The P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil are indicated for use as diagnostic device extensions for Philips 3.0 T MR Systems to produce cross-sectional spectroscopy images and/or spectra in any orientation of the internal structure of the whole body, e.g. of the calf, liver or heart. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K163661
Methodology: https://510kreport.com/methodology