Belmont Autopan-Pan Oramic, 098E Cephalometric-Rad
FDA 510(k) K852019 · Belmont Equipment Corp.
510(k) numberK852019
Submission
- Device name
- Belmont Autopan-Pan Oramic, 098E Cephalometric-Rad
- Applicant
- Belmont Equipment Corp.
Somerset, NJ, US - Received
- May 8, 1985
- Decision date
- June 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113360 | Medical Image Processing UnitEAP · Special | Humanray Co,Ltd | 02/07/2012SE |
| K102573 | Provu (TM) Dental X-Ray SystemEAP · Traditional | Advanced Image Science, Inc. | 06/30/2011SE |
| K093453 | Modification to Computed Oral Radiology SystemEAP · Special | Schick Technologies, Inc. | 11/30/2009SE |
| K080738 | Dentron SensorEAP · Traditional | Dentron Systems, LLC | 05/13/2008SE |
| K052422 | The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)EAP · Special | Flow X-Ray Corp. | 09/27/2005SE |
| K041385 | Modification to Computed Oral Radiology SystemEAP · Special | Schick Technologies, Inc. | 06/07/2004SE |
| K960819 | Heliodent DSEAP · Traditional | Pelton & Crane Co. | 03/29/1996SE |
| K960028 | Orthoralix SD2 & S Panoramic Dental X-Ray SystemEAP · Traditional | Dentsply Intl. | 03/01/1996SE |
| K953936 | AtlantisEAP · Traditional | Trophy Radiologie | 12/28/1995SE |
| K954565 | Explor-X (Azteh) HFEAP · Traditional | Chicago X-Ray Systems, Inc. | 10/27/1995SE |
More from Chicago X-Ray Systems, Inc.
| 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 |
| K874238 | Model 2001 CP, Photon I, Dental, Intraoral X-RayEHD · Traditional | 12/07/1987SE |
| 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 |
| 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 Belmont Autopan-Pan Oramic, 098E Cephalometric-Rad cleared by the FDA?
Belmont Autopan-Pan Oramic, 098E Cephalometric-Rad (K852019) received a 510(k) decision of Substantially Equivalent on June 5, 1985, 28 days after the submission was received.
What is the product code of K852019?
The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.