Diagnostic devices · 21 CFR 872 Subpart B
X-Ray Collimator
FDA device type “Collimator, X-Ray”.
- Companies listing it
- 44 makers
- Brands and models
- 3
- 510(k) clearances
- 50 in five years
- FDA name
- Collimator, X-Ray
510(k) clearances per year, 1976–2026
Companies that list EHB
4 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | X ray sensor holder | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | X ray sensor holder | — | — |
| DuPhaMed B.V. | Netherlands | Maker | dental x-ray sensor holder | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 25 Sep 1992 | K921355 | WINGMASTER | Innovators, Inc. |
| 9 Oct 1990 | K903012 | AUDIOPRAT ENDOSCOPE | S.C.D.P.I. of Florida, Inc. |
| 21 Feb 1984 | K834606 | X-RAY COLLIMATOR X-CJD | Knochen Dental Laboratory |
| 13 Jan 1984 | K833558 | X-RAY SHIELD | Moyco Industries, Inc. |
| 4 Dec 1978 | K781675 | X-RAY COLLIMATOR | General X-Ray, Inc. |
Official records: FDA product classification for EHB · 21 CFR 872.1840.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026