# K091114: TXRX 1.5T CP Head Coil; TXRX 3T CP Head Coil

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics
- Decided: May 1, 2009 after 14 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 K932271 (1994). 4 ancestors in all.
217 later devices descend from it; 2 cite it directly.
19 of 222 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021262: Magnetom Symphony Quadrature TX/RX Head Coil, Usa Instruments, Inc. (2002) Summary page 2.
- K021330: Magnetom Trio Quadrature TX/RX Head Coil, Usa Instruments, Inc. (2002) Summary page 2.

## Most influential descendants
- 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
- K151579: MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit (2015), 85 descendants of its own
- K153343: MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit (2016), 84 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own

## Indications for use
For use with a 1.5T Siemens Avanto/Espree or 3T Siemens Trio a TIM/Verio magnetic resonance scanner to produce diagnostic images of the head that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K091114
Methodology: https://510kreport.com/methodology