Nexus DR Digital X-Ray Imaging System (with vSharp)
FDA 510(k) K193238 · Varex Imaging Corporation
510(k) numberK193238
Submission
- Device name
- Nexus DR Digital X-Ray Imaging System (with vSharp)
- Applicant
- Varex Imaging Corporation
Liverpool, NY, US - Received
- November 25, 2019
- Decision date
- December 20, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
|---|---|---|
| K253103 | Nexus DRF Digital X-ray Imaging SystemJAA · Traditional | 05/29/2026SE |
| K190146 | Nexus DR Digital X-ray Imaging SystemMQB · Special | 03/08/2019SE |
| K183212 | Nexus DR Digital X-ray Imaging System with stitchingMQB · Special | 12/07/2018SE |
| K181526 | XRpad2 4343 HWC-M Flat Panel DetectorMQB · Special | 07/03/2018SE |
| K172951 | Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)MQB · Special | 10/24/2017SE |
| K171138 | Nexus DR Digital X-ray Imaging SystemMQB · Special | 05/17/2017SE |
Questions and answers
When was Nexus DR Digital X-Ray Imaging System (with vSharp) cleared by the FDA?
Nexus DR Digital X-Ray Imaging System (with vSharp) (K193238) received a 510(k) decision of Substantially Equivalent on December 20, 2019, 25 days after the submission was received.
What is the product code of K193238?
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.