# K063373: Flex Loop Coil Set 3T

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG
- Decided: Nov 17, 2006 after 9 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: 3 generations back to K971684 (1997). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971684: Magnetom Project 047 System (Numaris 3.5 Software), Siemens Medical Solutions USA, Inc. (1997) Summary page 3.
- K032428: Magnetom Avanto MR System, Siemens Medical Solutions USA, Inc. (2003) Summary page 3.
- K050200: Magnetom Trio a Tim System, Siemens Medical Solutions USA, Inc. (2005) Summary page 3.

## Most influential descendants
- K083578: Noras CPC Multifunctional Coil (2009), 1 descendant of its own
- K070629: Flex and Loop Coil Set 1.5 T (2007), 1 descendant of its own
- K140252: 16 CH Multipurpose Coil Variety (2014), 0 descendants of its own
- K110373: Temporomanibular Coil 15 (2011), 0 descendants of its own

## Indications for use
The intended use of the Flex Loop Coil Set 3 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in the MAGNETOM 3 T Trio, a Tim System, the Flex Loop Coils are indicated for use as a diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the MAGNETOM 3 T Trio, a Tim System with the Flex Loop Coils reflect the spatial distribution of protons (hydogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The intended use of the MAGNETOM 3 T Trio, a Tim System is not affected in any way by the use of the new Flex Loop Coil Set 3 T.

Source page: https://510kreport.com/device/K063373
Methodology: https://510kreport.com/methodology