# K012491: Machnet Carotids Coil Array Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Machnet BV
- Decided: Oct 24, 2001 after 82 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 K001210 (2000). 1 ancestor in all.
229 later devices descend from it; 4 cite it directly.
19 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001210: HI-Res 9000 Phased Array Carotid Coil, Usa Instruments, Inc. (2000) Summary page 1.

## Most influential descendants
- K083166: Specialty Coils for the Magnetom Essenza (2009), 222 descendants of its own
- K103275: Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR Systems (2011), 221 descendants of its own
- K111242: Magnetom Aera and Magnetom Skyra (2011), 220 descendants of its own
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio (2012), 215 descendants of its own
- K141977: Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel (2014), 115 descendants of its own

## Indications for use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of Carotid structures that can be interpreted by a trained physician. The Machnet Carotids Coil is designed to provide coverage of the carotid arteries and associated vasculature from the aortic arch through the Circle-of-Willis. Anatomic Regions: Head and Neck Vasculature. Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging; The GE Signa system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time TI, spin-spin relaxation time T2) and (3) display the vasculature of the head and neck regions specifically the carotid arteries and associated soft tissue. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K012491
Methodology: https://510kreport.com/methodology