Kodak RVG 6500 System and Kodak RVG 6500 Ips System
FDA 510(k) K093478 · Trophy
510(k) numberK093478
Submission
- Device name
- Kodak RVG 6500 System and Kodak RVG 6500 Ips System
- Applicant
- Trophy
Croissy-Beaubourg, FR - Received
- November 9, 2009
- Decision date
- April 26, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code MUH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251793 | SOTA Cloud Smart Sensor (1.5)MUH · Traditional | Sota Cloud Corp. | 03/03/2026SE |
| K252570 | EzSensor HD, EzSensor UHDMUH · Special | Qpix Solutions, Inc. | 11/10/2025SE |
| K250687 | Cocoon Solo (DX-7020s)MUH · Traditional | Dexcowin Global, Inc. | 10/24/2025SE |
| K251206 | Digital X-Ray DentiMax Pro Imaging SystemMUH · Traditional | Dentimax, Inc. | 09/24/2025SE |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan…MUH · Traditional | VATECH Co., Ltd. | 10/25/2024SE |
| K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF)MUH · Special | Qpix Solutions, Inc. | 10/11/2024SE |
| K241649 | DUO1 and DUO2MUH · Traditional | Zinnovi, Inc. | 07/05/2024SE |
| K232325 | RAYSCAN a-ExpertMUH · Traditional | Ray Co., Ltd. | 04/18/2024SE |
| K231660 | Digital image scanner of dentalMUH · Traditional | Jiangsu Dynamic Medical Technology Co., Ltd. | 12/20/2023SE |
| K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2…MUH · Traditional | Dental Imaging Technologies Corporation | 11/21/2023SE |
More from Dental Imaging Technologies Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K193390 | CS Model+PNN · Traditional | 04/02/2020SE |
| K200183 | CS 9600OAS · Traditional | 03/13/2020SE |
| K181136 | CS 9600OAS · Traditional | 05/24/2018SE |
| K173622 | CS ImagingLLZ · Traditional | 01/16/2018SE |
| K151087 | CS 8100SC, CS8100SC AccessMUH · Traditional | 08/21/2015SE |
| K151837 | CS 3D ImagingLLZ · Traditional | 08/19/2015SE |
| K141607 | Dental Imaging SoftwareLLZ · Traditional | 09/18/2014SE |
| K133406 | CS 8100 3DOAS · Traditional | 03/14/2014SE |
| K120975 | CS 8100 CS 8100 AccessMUH · Traditional | 06/22/2012SE |
| K113419 | CS ImagingLLZ · Traditional | 02/16/2012SE |
Questions and answers
When was Kodak RVG 6500 System and Kodak RVG 6500 Ips System cleared by the FDA?
Kodak RVG 6500 System and Kodak RVG 6500 Ips System (K093478) received a 510(k) decision of Substantially Equivalent on April 26, 2010, 168 days after the submission was received.
What is the product code of K093478?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.