Vivix-S VW
FDA 510(k) K200418 · Vieworks Co., Ltd.
510(k) numberK200418
Submission
- Device name
- Vivix-S VW
- Applicant
- Vieworks Co., Ltd.
Anyang-Si, KR - Received
- February 20, 2020
- Decision date
- March 18, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MQB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253800 | 0909FCE, 0909FCE-HSMQB · Traditional | Rayence Co., Ltd. | 07/31/2026SE |
| K260820 | Vivix-S 4386W (FXRD-4386WA)MQB · Special | Vieworks Co., Ltd. | 06/18/2026SE |
| K252996 | Universal 1417PIMQB · Abbreviated | Konica Minolta Healthcare Americas, Inc. | 06/12/2026SE |
| K252911 | Lux HD 2530 detector (Lux HD 2530)MQB · Special | Iray Imaging Technology (Haining) Limited | 10/09/2025SE |
| K250211 | Yushan X-Ray Flat Panel DetectorMQB · Traditional | Innocare Optoelectronics Corp. | 07/22/2025SE |
| K250665 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 06/17/2025SE |
| K243734 | Wireless/ Wired X-Ray Flat Panel DetectorsMQB · Special | Allengers Medical Systems Limited | 04/18/2025SE |
| K242770 | Expd 114; Expd 114G; Expd 114P; Expd 114PGMQB · Special | DRTECH Corporation | 03/20/2025SE |
| K243443 | Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…MQB · Special | DRTECH Corporation | 03/19/2025SE |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB · Traditional | Iray Imaging Technology (Haining) Limited | 03/18/2025SE |
More from Iray Imaging Technology (Haining) Limited
| 510(k) | Device | Decision |
|---|---|---|
| K260820 | Vivix-S 4386W (FXRD-4386WA)MQB · Special | 06/18/2026SE |
| K254092 | Bellalun 2D (VDMS-1000S)MUE · Traditional | 05/28/2026SE |
| K251410 | VXvueLLZ · Traditional | 11/04/2025SE |
| K241113 | Vivix-MMUE · Traditional | 01/16/2025SE |
| K241125 | Vivix-S 1751SMQB · Traditional | 11/15/2024SE |
| K220239 | Solid State X-ray Imager(Model: FXRD-4386WB)MQB · Traditional | 09/13/2022SE |
| K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)MQB · Traditional | 07/20/2022SE |
| K190611 | Vivix-S 1751SMQB · Traditional | 04/08/2019SE |
| K181003 | Vivix-S 1717VMQB · Traditional | 05/15/2018SE |
| K163703 | Vivix-S 1417NMQB · Traditional | 02/08/2017SE |
Questions and answers
When was Vivix-S VW cleared by the FDA?
Vivix-S VW (K200418) received a 510(k) decision of Substantially Equivalent on March 18, 2020, 27 days after the submission was received.
What is the product code of K200418?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.