Universal-X (USA) or /Krystal-X (Europe)
FDA 510(k) K053172 · Owandy Sas
510(k) numberK053172
Submission
- Device name
- Universal-X (USA) or /Krystal-X (Europe)
- Applicant
- Owandy Sas
New York, NY, US - Received
- November 14, 2005
- Decision date
- June 9, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K232325 | RAYSCAN a-ExpertMUH · Traditional | Ray Co., Ltd. | 04/18/2024SE |
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| 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
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|---|---|---|
| K133271 | Opteo, Videograph HDMUH · Special | 04/28/2014SE |
| K130443 | I-Max Touch 3DOAS · Abbreviated | 06/14/2013SE |
| K093105 | VisteoEHD · Abbreviated | 10/18/2010SE |
| K083057 | I-Max TouchMUH · Traditional | 06/02/2009SE |
| K070505 | Krystal-X WifiMUH · Traditional | 04/05/2007SE |
| K062403 | Imax Ceph Digital X-Ray SensorMUH · Traditional | 11/14/2006SE |
Questions and answers
When was Universal-X (USA) or /Krystal-X (Europe) cleared by the FDA?
Universal-X (USA) or /Krystal-X (Europe) (K053172) received a 510(k) decision of Substantially Equivalent on June 9, 2006, 207 days after the submission was received.
What is the product code of K053172?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.