# K070629: Flex and Loop Coil Set 1.5 T

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions
- Decided: Mar 26, 2007 after 19 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: 4 generations back to K971684 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063373: Flex Loop Coil Set 3T, Siemens AG (2006) Summary page 4.

## Most influential descendants
- K110373: Temporomanibular Coil 15 (2011), 0 descendants of its own

## Indications for use
The intended use of the Flex and Loop Coil Set 1.5 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in the MAGNETOM Avanto, Espree and Symphony a Tim System, the Flex and 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 Avanto, Espree and Symphony a Tim System with the Flex and Loop Coils reflect the spatial distribution of protons (hydrogen 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 Avanto, Espree and Symphony a Tim System is not affected in any way by the use of the new Flex and Loop Coil Set 1.5T.

Source page: https://510kreport.com/device/K070629
Methodology: https://510kreport.com/methodology