# K063274: Acculoc Breast Localization System

- Pathway: 510(k) (Traditional)
- Applicant: Northwest Medical Physics Equipment, Inc.
- Decided: Dec 12, 2006 after 43 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The indications for use of ACCULOC Breast Localization System (formerly MAMMOLOC) are lesions requiring extracranial stereotactic radiotherapy or radiosurgery to the breast. The software is used to determine the precise location of the target with respect to implanted fiducials.

Source page: https://510kreport.com/device/K063274
Methodology: https://510kreport.com/methodology