# K022488: Model Obc-63 Breast Array Coil

- Pathway: 510(k) (Special)
- Applicant: Mri Devices Corp.
- Decided: Aug 23, 2002 after 25 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K060547: Access Breast Coil 4/SMS (2006), 0 descendants of its own

## Recalls of this device
- Nov 4, 2024 · Class II · Z-0545-2025: Potential safety issue where a patient may be harmed while preparing for or during a scan.

## Indications for use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K022488
Methodology: https://510kreport.com/methodology