Trophy Radiologie RVG Radiovisiography
FDA 510(k) K950533 · Trophy Radiologie
510(k) numberK950533
Submission
- Device name
- Trophy Radiologie RVG Radiovisiography
- Applicant
- Trophy Radiologie
Vincennes, Cedex (Paris), FR - Received
- February 3, 1995
- Decision date
- June 30, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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.
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| K023346 | TrophypanMUH · Traditional | 01/03/2003SE |
| K012514 | Digipan / DpiMUH · Traditional | 12/21/2001SE |
| K991455 | Orthoslice OS1000 Series; Panoramic Orthoslice Os 1000: OS1000, OS1000E Panoramic and…EHD · Traditional | 06/25/1999SE |
| K991912 | Modification to DigipanEHD · Traditional | 06/22/1999SE |
| K961826 | DigipanEHD · Traditional | 09/23/1996SE |
| K962337 | Elitys or Elitys-EEHD · Traditional | 07/25/1996SE |
| K953936 | AtlantisEAP · Traditional | 12/28/1995SE |
| K951074 | Stomavision (STV)EIA · Traditional | 09/19/1995SE |
Questions and answers
When was Trophy Radiologie RVG Radiovisiography cleared by the FDA?
Trophy Radiologie RVG Radiovisiography (K950533) received a 510(k) decision of Substantially Equivalent on June 30, 1995, 147 days after the submission was received.
What is the product code of K950533?
The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.