# K020289: Mics Intervention Aid, Catalog # Mics-Mia and Mics-Mias

- Pathway: 510(k) (Traditional)
- Applicant: Machnet BV
- Decided: Apr 24, 2002 after 86 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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 K000832 (2000). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000832: Sterotactic Localization Device (SLD), Philips Medical Systems North America, Inc. (2000) Summary page 1.
- K010570: Breast Immobiization and Biopsy Device MR-Biopsy 160, Mri Devices Corp. (2001) Summary page 1.
- K010773: Breast Biopsy Device/Magnetom Systems, Siemens Medical Solutions USA, Inc. (2001) Summary page 2.

## Most influential descendants
- K090223: Icad Breast Interventional Planning Software, Model D70024 (2009), 0 descendants of its own
- K071534: Confirma Breast Mri Interventional Components (2007), 0 descendants of its own
- K041020: Cadstream Version 3.1 (2004), 0 descendants of its own

## Indications for use
The “MICS INTERVENTION AID (MICS-MIA and MICS-MIAS)” is for use in conjunction with a Magnetic Resonance Scanner and the Machnet Bilateral Open Breast Coil to localize lesions in female breasts and perform needle biopsies accurately. For use by a trained physician.

Source page: https://510kreport.com/device/K020289
Methodology: https://510kreport.com/methodology