# K013985: Machnet Bilateral Open Breast Coil. Catalog # Mics-GSXX

- Pathway: 510(k) (Traditional)
- Applicant: Machnet BV
- Decided: Feb 1, 2002 after 60 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: 1 generation back to K003340 (2000). 1 ancestor in all.
1 later device descends 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)
- K003340: Obc-149 Breast Array Coil, Mri Devices Corp. (2000) Summary page 1.

## Most influential descendants
- K052045: Access Breast Coil (2005), 0 descendants of its own

## Indications for use
The Machnet Bilateral Open Breast Coil, Catalog Number MICS-GSXX, is for use in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissues that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K013985
Methodology: https://510kreport.com/methodology