# Lorad, A Hologic Co.

- Location (FDA's records): Danbury, CT
- FDA decisions: 5 (2001–2013): 5 510(k) clearances
- Product codes: IZH (5)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hologic, Inc.: 2 (https://510kreport.com/company/hologic)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)

## Firms that cite its devices most
- Hologic, Inc.: 5 (https://510kreport.com/company/hologic)
- Siemens Medi Cal Solutions, Inc.: 1 (https://510kreport.com/company/siemens-medi-cal-solutions)

## Its most-cited devices
- K122836: Affirm Breast Biopsy Guidance System (2013), cited by 3
- K030666: Multicare Platinum System and Accessories (2003), cited by 2
- K071542: Digital Stereoloc II (2007), cited by 1

## Recent decisions
- K122836: Affirm Breast Biopsy Guidance System (Jan 11, 2013)
- K071542: Digital Stereoloc II (Jul 5, 2007)
- K030666: Multicare Platinum System and Accessories (Mar 25, 2003)
- K013290: Modified 650 Mammography System (Oct 24, 2001)
- K011987: Modified M-IV Mammography System (Jul 11, 2001)

Source page: https://510kreport.com/company/lorad-a-hologic