FDA applicant

Lorad, A Hologic Co.

Danbury, CT5 decisions2001–20133 recalls

FDA records 5 decisions for Lorad, A Hologic Co. (Danbury, CT) from 2001 to 2013: 5 510(k) clearances. All are in product code IZH (System, X-Ray, Mammographic). Its devices cite 3 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Lorad, A Hologic Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Lorad, A Hologic Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lorad, A Hologic Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Lorad”

FDA records each applicant name separately; these may or may not be the same firm.

Lorad Corp. 12 Lorad Medical Systems, Inc. 8

Lorad, A Hologic Co.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Lorad”