# K071534: Confirma Breast Mri Interventional Components

- Pathway: 510(k) (Traditional)
- Applicant: Confirma, Inc.
- Decided: Jul 9, 2007 after 34 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: 2 generations back to K000832 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001303: Breast Immobilization Device MR-by 160, Mri Devices Corp. (2000) Summary page 3.
- K020289: Mics Intervention Aid, Catalog # Mics-Mia and Mics-Mias, Machnet BV (2002) Summary page 3.
- K052704: Model BBD Breast Immobilization and Biopsy Device, Invivo Corp. (2005) Summary page 3.
- K052987: Breast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA and BI 160-CC, Noras Rontgen-Und Medizintechnik GmbH (2005) Summary page 3.

## Indications for use
The Confirma Breast MRI Interventional Components are intended to be used in conjunction with a magnetic resonance scanner and the Confirma Access Breast Coil designs to permit MRI-guided interventional procedures, such as breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

Source page: https://510kreport.com/device/K071534
Methodology: https://510kreport.com/methodology