Lorad Corp.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Lorad Corp.” (first 1994, latest 1999), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 82 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 | 0 | — |
| 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 | 11 | 11 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
Review panels
- Radiology (11)
- General and Plastic Surgery (1)
Most recent Lorad Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992280 | LORAD 1-650 (INTERNATIONAL 650) | IZH | 1999-09-03 | 58 |
| K974460 | LITE TOUCH ERBIUM LASER TREATMENT SYSTEM | GEX | 1998-01-16 | 52 |
| K973631 | LORAD M-III ELITE (M-III E) | IZH | 1997-12-23 | 90 |
| K952210 | LORAD STEROLOC II | IZH | 1995-07-24 | 75 |
| K945241 | LORAD M-IV, LORAD M-IVI | IZH | 1995-03-31 | 155 |
| K950608 | DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION | IZH | 1995-03-02 | 21 |
| K945496 | MAMMOGRAPHIC X-RAY UNIT | IZH | 1994-12-27 | 49 |
| K945272 | RHODIUM FILTER | IZH | 1994-12-14 | 47 |
| K934868 | LORAD TRANSPO | IZH | 1994-10-14 | 367 |
| K934870 | LORAD D-550 | IZH | 1994-01-31 | 111 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lorad Corp..
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 Medical Systems, Inc. (8 510(k)s)
- Lorad, A Hologic Co. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lorad Corp.?
FDA lists 12 510(k) clearances under the applicant name “Lorad Corp.” (first 1994, latest 1999), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lorad Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lorad Corp. is 82 days.
Which FDA product codes appear under Lorad Corp.?
The most frequent FDA product codes under this applicant name are IZH (System, X-Ray, Mammographic, 11); GEX (Powered Laser Surgical Instrument, 1).
Next steps
- See all 12 Lorad Corp. clearances with predicates and recalls
- Run predicate analysis for product code IZH, Lorad Corp.'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.