Company ยท US
Lorad, A Hologic Co.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2013. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 2013 | K122836 | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM Lorad, A Hologic Co. | IZH |
| Jul 5, 2007 | K071542 | DIGITAL STEREOLOC II Lorad, A Hologic Co. | IZH |
| Mar 25, 2003 | K030666 | MULTICARE PLATINUM SYSTEM AND ACCESSORIES Lorad, A Hologic Co. | IZH |
| Oct 24, 2001 | K013290 | MODIFIED 650 MAMMOGRAPHY SYSTEM Lorad, A Hologic Co. | IZH |
| Jul 11, 2001 | K011987 | MODIFIED M-IV MAMMOGRAPHY SYSTEM Lorad, A Hologic Co. | IZH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2008 | Lorad, A Hologic, Inc. Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002; Hologic, Danbury CT 06810 Terminated |
MUE | None listed |