# K103275: Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 11, 2011 after 67 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: 7 generations back to K971684 (1997). 14 ancestors in all.
221 later devices descend from it; 1 cites it directly.
20 of 236 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071925: Magnetom Essenza, Siemens Medical Solutions USA, Inc. (2007) Summary page 2.
- K083166: Specialty Coils for the Magnetom Essenza, Siemens Medical Solutions USA, Inc. (2009) Summary page 2.
- K072237: Magnetom Verio, Siemens Medical Solutions USA, Inc. (2007) Summary page 2.

## Most influential descendants
- 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
- 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

## Indications for use
The specialty coils are indicated for use in conjunction with the MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T Systems, magnetic resonance diagnostic devices (MRDD), which produce transverse, sagittal, coronal and oblique cross sectional images, and display the internal structure and/or function of the body. These images, when interpreted by a trained physician, yield information that may assist in diagnosis. The intended use of the Aera and Skyra Systems is not affected by the use of the new specialty coils.

Source page: https://510kreport.com/device/K103275
Methodology: https://510kreport.com/methodology