Image Works Panoura
FDA 510(k) K122806 · Mic International
510(k) numberK122806
Submission
- Device name
- Image Works Panoura
- Applicant
- Mic International
Tokyo, JP - Received
- September 13, 2012
- Decision date
- March 8, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MUH
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|---|---|---|---|
| K251793 | SOTA Cloud Smart Sensor (1.5)MUH · Traditional | Sota Cloud Corp. | 03/03/2026SE |
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| 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 |
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| 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 |
Questions and answers
When was Image Works Panoura cleared by the FDA?
Image Works Panoura (K122806) received a 510(k) decision of Substantially Equivalent on March 8, 2013, 176 days after the submission was received.
What is the product code of K122806?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.