Vivi Ergon-X HF
FDA 510(k) K120318 · Vivi S.R.L.
510(k) numberK120318
Submission
- Device name
- Vivi Ergon-X HF
- Applicant
- Vivi S.R.L.
Imoa, IT - Received
- February 2, 2012
- Decision date
- March 6, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
Questions and answers
When was Vivi Ergon-X HF cleared by the FDA?
Vivi Ergon-X HF (K120318) received a 510(k) decision of Substantially Equivalent on March 6, 2012, 33 days after the submission was received.
What is the product code of K120318?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.