# K011987: Modified M-IV Mammography System

- Pathway: 510(k) (Special)
- Applicant: Lorad, A Hologic Co.
- Decided: Jul 11, 2001 after 15 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: 3 (0 Class I)
- 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. The FDA summary names no predicate by number.

## Recalls of this device
- May 13, 2014 · Class II · Z-1701-2014: Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
- Jan 14, 2004 · Not classified · Z-0148-04: System failed to meet the mA's accuracy specfications at low mA's values
- Jan 14, 2004 · Not classified · Z-0149-04: System failed to meet the mA's accuracy specfications at low mA's values

## Indications for use
The Modified M-IV Mammography System is intended to produce radiographic images of the breast. Its specific intended use is for screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnostic mammography includes the production of magnified images for more thorough examination of areas of the breast determined suspicious through screening mammography, special views, spot compression views, and the production of images used by a physician in preparation for biopsy.

Source page: https://510kreport.com/device/K011987
Methodology: https://510kreport.com/methodology