FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Solid State X-ray Imager(Model: FXRD-4386WB)
K Number: K220239
·
Decision Sep 13, 2022
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
21
Review Days
228
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Basic Information
- Device Name
- Solid State X-ray Imager(Model: FXRD-4386WB)
- K Number
- K220239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vieworks Co., Ltd.
- Date Received
- January 28, 2022
- Decision Date
- September 13, 2022
- Product Code
- MQB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQB), ordered by most recent decision date.
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Other Clearances by Vieworks Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260820 | VIVIX-S 4386W (FXRD-4386WA) | Jun 18, 2026 | Substantially Equivalent |
| K254092 | Bellalun 2D (VDMS-1000S) | May 28, 2026 | Substantially Equivalent |
| K251410 | VXvue | Nov 4, 2025 | Substantially Equivalent |
| K241113 | VIVIX-M | Jan 16, 2025 | Substantially Equivalent |
| K241125 | VIVIX-S 1751S | Nov 15, 2024 | Substantially Equivalent |
| K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | Jul 20, 2022 | Substantially Equivalent |
| K200418 | VIVIX-S VW | Mar 18, 2020 | Substantially Equivalent |
| K190611 | VIVIX-S 1751S | Apr 8, 2019 | Substantially Equivalent |
| K181003 | VIVIX-S 1717V | May 15, 2018 | Substantially Equivalent |
| K163703 | VIVIX-S 1417N | Feb 8, 2017 | Substantially Equivalent |