# K010773: Breast Biopsy Device/Magnetom Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 30, 2001 after 77 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020289: Mics Intervention Aid, Catalog # Mics-Mia and Mics-Mias (2002), 3 descendants of its own
- 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

## Recalls of this device
- Oct 5, 2005 · Not classified · Z-0138-06: If the recommended workflow is not followed and the worksheets are printed after moving the patient table out of isocenter, the offset values will be incorrect. This could result in a biopsy being per

Source page: https://510kreport.com/device/K010773
Methodology: https://510kreport.com/methodology