Bennett X-Ray Corp.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Bennett X-Ray Corp.” (first 1977, latest 1997), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 71 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 7 | 7 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 4 | 4 |
| IYB | Tube Mount, X-Ray, Diagnostic | 3 | 3 |
| IZL | System, X-Ray, Mobile | 2 | 2 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
| IXG | Phantom, Anthropomorphic, Radiographic | 1 | 1 |
| IZF | System, X-Ray, Tomographic | 1 | 1 |
| IZX | Collimator, Manual, Radiographic | 1 | 1 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (22)
Most recent Bennett X-Ray Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964576 | PROFILE MAMMOGRAPHY SYSTEM (M-PRO) | IZH | 1997-01-10 | 57 |
| K952672 | VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEM | KPR | 1995-07-13 | 31 |
| K944978 | BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI | IZH | 1995-05-03 | 204 |
| K945962 | BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY | IZH | 1995-04-03 | 117 |
| K945749 | BENNETT X-RAY TOMOGRAPHY SYSTEM | IZF | 1995-02-15 | 84 |
| K945731 | HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS | IZO | 1995-02-15 | 85 |
| K940701 | BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH | IZH | 1994-04-28 | 71 |
| K935649 | WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY | KPR | 1994-02-09 | 78 |
| K935068 | RADIOGRAPHIC GENERATOR HFQ-WHIS | IZO | 1993-12-13 | 49 |
| K925725 | CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR | IZH | 1993-02-26 | 105 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bennett X-Ray 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.
- Bennett X-Ray Technologies (2 510(k)s)
- Bennett and Assoc., Inc. (1 510(k)s)
- Bennett Ergonomic Labs, Inc. (1 510(k)s)
- Bennett Jacoby, Dds, Ms, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bennett X-Ray Corp.?
FDA lists 23 510(k) clearances under the applicant name “Bennett X-Ray Corp.” (first 1977, latest 1997), across 10 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 Bennett X-Ray Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bennett X-Ray Corp. is 71 days.
Which FDA product codes appear under Bennett X-Ray Corp.?
The most frequent FDA product codes under this applicant name are IZH (System, X-Ray, Mammographic, 7); IZO (Generator, High-Voltage, X-Ray, Diagnostic, 4); IYB (Tube Mount, X-Ray, Diagnostic, 3).
Next steps
- See all 23 Bennett X-Ray Corp. clearances with predicates and recalls
- Run predicate analysis for product code IZH, Bennett X-Ray 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.