D&R X-Ray Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “D&R X-Ray Products, Inc.” (first 1985, latest 1986), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| IXR | Table, Radiographic, Tilting | 1 | 1 |
| IYB | Tube Mount, X-Ray, Diagnostic | 1 | 1 |
| IZW | Collimator, Automatic, Radiographic | 1 | 1 |
| IZX | Collimator, Manual, Radiographic | 1 | 1 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 1 | 1 |
Review panels
- Radiology (5)
Most recent D&R X-Ray Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862734 | CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND | IYB | 1986-08-01 | 11 |
| K861942 | COLLIMATOR MODEL A280BLE & MODEL A280-BLM | IZW | 1986-07-25 | 66 |
| K861941 | COLLIMATOR MODEL A280BLMD & MODEL A280BLMP | IZX | 1986-07-25 | 66 |
| K861940 | RADIOGRAPHIC TABLES MODELS A71OS-T,A71OT-T,A71OB-T | IZZ | 1986-05-29 | 9 |
| K850948 | TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER | IXR | 1985-04-10 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named D&R X-Ray Products, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under D&R X-Ray Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “D&R X-Ray Products, Inc.” (first 1985, latest 1986), across 5 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 D&R X-Ray Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name D&R X-Ray Products, Inc. is 34 days.
Which FDA product codes appear under D&R X-Ray Products, Inc.?
The most frequent FDA product codes under this applicant name are IXR (Table, Radiographic, Tilting, 1); IYB (Tube Mount, X-Ray, Diagnostic, 1); IZW (Collimator, Automatic, Radiographic, 1).
Next steps
- See all 5 D&R X-Ray Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IXR, D&R X-Ray Products, 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, 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.