Model 2001 CP, Photon I, Dental, Intraoral X-Ray
FDA 510(k) K874238 · Belmont Equipment Corp.
510(k) numberK874238
Submission
- Device name
- Model 2001 CP, Photon I, Dental, Intraoral X-Ray
- Applicant
- Belmont Equipment Corp.
Somerset, NJ, US - Received
- October 15, 1987
- Decision date
- December 7, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| K260367 | Portable Dental X-ray System Model PDX novaEHD · Traditional | PDX Co., Ltd. | 05/27/2026SE |
| K253864 | NOMAD Pro 3EHD · Traditional | Dental Imaging Technologies Corporation | 03/20/2026SE |
| K252110 | Dental X-RAY Unit (AJX200)EHD · Traditional | Guangzhou Ajax Medical Equipment Co., Ltd. | 03/12/2026SE |
| K254018 | Portable Dental X-ray Device (GT-1)EHD · Traditional | Guilin Refine Medical Instrument Co., Ltd. | 02/19/2026SE |
| K252909 | Diagnostic X-Ray Equipment Model POCT22EHD · Traditional | Ningbo Runyes Medical Instrument Co., Ltd. | 02/03/2026SE |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )EHD · Special | Guilin Woodpecker Medical Instrument Co., Ltd. | 09/04/2025SE |
| K242185 | Rextar ProEHD · Traditional | Raypia Co., Ltd. | 12/04/2024SE |
| K242591 | XERO-alphaEHD · Traditional | DRTECH Corporation | 11/01/2024SE |
| K241963 | WerayEHD · Traditional | Picopack Co., Ltd. | 07/30/2024SE |
| K241305 | LifeRay Intraoral Handheld X-ray SystemEHD · Traditional | Lucas Lifecare | 07/05/2024SE |
More from Lucas Lifecare
| 510(k) | Device | Decision |
|---|---|---|
| K000799 | Belmont Unit, Model 2000 SeriesEIA · Traditional | 05/17/2000SE |
| K983661 | Belmont Unit, Model 6000 Series and 7500 SeriesEIA · Traditional | 01/12/1999SE |
| K963699 | Belray/Model 096, Dental Intraoral X-RayEHD · Traditional | 12/23/1996SE |
| K900681 | Panoramic Model X-Caliber X-RayEAP · Traditional | 05/23/1990SE |
| K870300 | Belmont, Podiatry X-Ray - Remex, Model PD75KPR · Traditional | 03/25/1987SE |
| K861328 | New Belmont Model, MC-5 Dental, Intraoral X-RayEAP · Traditional | 04/24/1986SE |
| K852019 | Belmont Autopan-Pan Oramic, 098E Cephalometric-RadEAP · Traditional | 06/05/1985SE |
| K844554 | Belmont Autopan-Panoramic 098 Cephalometric-RadiogIWZ · Traditional | 02/21/1985SE |
| K834279 | Acuray 071A Dental Intraoral X-RayEAP · Traditional | 12/29/1983SE |
| K832065 | Acuracy 071, Dental, Intraoral-X-RayEAP · Traditional | 09/12/1983SE |
Questions and answers
When was Model 2001 CP, Photon I, Dental, Intraoral X-Ray cleared by the FDA?
Model 2001 CP, Photon I, Dental, Intraoral X-Ray (K874238) received a 510(k) decision of Substantially Equivalent on December 7, 1987, 53 days after the submission was received.
What is the product code of K874238?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.