Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of LoradLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Lorad, A Hologic Co. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Jan 11, 2013: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM.
| Date | Record | Source |
|---|---|---|
| Jan 11, 2013 | AFFIRM BREAST BIOPSY GUIDANCE SYSTEMK122836 · IZH | 510(k) clearances |
| Jul 5, 2007 | DIGITAL STEREOLOC IIK071542 · IZH | 510(k) clearances |
| Mar 25, 2003 | MULTICARE PLATINUM SYSTEM AND ACCESSORIESK030666 · IZH | 510(k) clearances |
| Oct 24, 2001 | MODIFIED 650 MAMMOGRAPHY SYSTEMK013290 · IZH | 510(k) clearances |
| Jul 11, 2001 | MODIFIED M-IV MAMMOGRAPHY SYSTEMK011987 · IZH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built