# K083166: Specialty Coils for the Magnetom Essenza

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 13, 2009 after 78 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: 6 generations back to K971684 (1997). 12 ancestors in all.
222 later devices descend from it; 2 cite it directly.
19 of 235 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032428: Magnetom Avanto MR System, Siemens Medical Solutions USA, Inc. (2003) Summary page 2.
- K071925: Magnetom Essenza, Siemens Medical Solutions USA, Inc. (2007) Summary page 2.
- K012491: Machnet Carotids Coil Array Assembly, Machnet BV (2001) Summary page 2.

## Most influential descendants
- 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
- K151579: MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit (2015), 85 descendants of its own

## Indications for use
The speciality coils are indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and/or function of the body. These images when interpreted by a trained physician yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K083166
Methodology: https://510kreport.com/methodology