Lorad Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Lorad Medical Systems, Inc.” (first 1984, latest 1992), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 131 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 | 5 | 5 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| JAC | System, X-Ray, Film Marking, Radiographic | 1 | 1 |
Review panels
- Radiology (8)
Most recent Lorad Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921962 | LORAD DIGITAL SPOT MAMMOGRAPHY | IZH | 1992-11-23 | 210 |
| K922619 | DIGITIZER, MODEL # 3-000A-1518 | IZH | 1992-07-01 | 33 |
| K913732 | MAMMOGRAPHIC X-RAY SYSTEM | IZH | 1992-02-03 | 167 |
| K913478 | RADIOGRAPHIC FILM MARKING SYSTEM | JAC | 1991-10-15 | 70 |
| K894935 | S-70 PORTABLE DENTAL X-RAY SYSTEM | EHD | 1990-04-25 | 265 |
| K894643 | RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT | IZL | 1989-12-14 | 143 |
| K882875 | STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY | IZH | 1988-11-07 | 119 |
| K842102 | LORAD | IZH | 1984-07-17 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Lorad Medical Systems, Inc..
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, A Hologic Co. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lorad Medical Systems, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Lorad Medical Systems, Inc.” (first 1984, latest 1992), across 4 product codes 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 Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lorad Medical Systems, Inc. is 131 days.
Which FDA product codes appear under Lorad Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are IZH (System, X-Ray, Mammographic, 5); EHD (Unit, X-Ray, Extraoral With Timer, 1); IZL (System, X-Ray, Mobile, 1).
Next steps
- See all 8 Lorad Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZH, Lorad Medical Systems, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.