# K973630: CP Breast Array Coil/Magnetom Harmony/Symphony System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 5, 1997 after 72 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MAGNETOM Harmony and Symphony: named in the summary without a submission number

## Most influential descendants
- K083255: 16CH AI Breast Coils 1.5 T and 3 T (2008), 1 descendant of its own
- K181948: 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil (2018), 0 descendants of its own

## Indications for use
The Siemens Magnetom CP Breast Array Coil is indicated for use as a diagnostic imaging device accessory to produce transverse, saggital, coronal and oblique images of the internal structures of the breast.

Source page: https://510kreport.com/device/K973630
Methodology: https://510kreport.com/methodology