Lorad, A Hologic Co.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Lorad, A Hologic Co.” (first 2001, latest 2013), across 1 product code in 1 review panel. Median 510(k) review time under this name: 22 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Hologic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 116 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | 5 | 5 |
Review panels
- Radiology (5)
Most recent Lorad, A Hologic Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122836 | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | IZH | 2013-01-11 | 116 |
| K071542 | DIGITAL STEREOLOC II | IZH | 2007-07-05 | 30 |
| K030666 | MULTICARE PLATINUM SYSTEM AND ACCESSORIES | IZH | 2003-03-25 | 22 |
| K013290 | MODIFIED 650 MAMMOGRAPHY SYSTEM | IZH | 2001-10-24 | 22 |
| K011987 | MODIFIED M-IV MAMMOGRAPHY SYSTEM | IZH | 2001-07-11 | 15 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-02-28.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Lorad Corp. (12 510(k)s)
- Lorad Medical Systems, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lorad, A Hologic Co.?
FDA lists 5 510(k) clearances under the applicant name “Lorad, A Hologic Co.” (first 2001, latest 2013), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lorad, A Hologic Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lorad, A Hologic Co. is 22 days.
Which FDA product codes appear under Lorad, A Hologic Co.?
The most frequent FDA product codes under this applicant name are IZH (System, X-Ray, Mammographic, 5).
Next steps
- See all 5 Lorad, A Hologic Co. clearances with predicates and recalls
- Run predicate analysis for product code IZH, Lorad, A Hologic Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.