FDA Registration
Active
🇰🇷 South Korea
Vieworks Co., Ltd.
Reg #: 3017585294
·
FEI: 3017585294
·
Expires 2026
Products
3
Proprietary Names
44
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Vieworks Co., Ltd.
- Registration Number
- 3017585294
- FEI Number
- 3017585294
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 25-7, Jeongnamsandan 2-gil, Jeongnam-myeon
- City
- Hwaseong-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K220239
Owner / Operator
- Firm Name
- Vieworks Co., Ltd.
- Operator Number
- 10024523
- Address
- 41-3, Burim-ro 170beon-gil, Dongan-gu
- City
- Anyang-si
- State
- Gyeonggi
- Postal Code
- 14055
- Country
- KR
- Correspondent
- Serin Park
US Agent
- Business Name
- Vieworks America Ltd.
- Contact Name
- Peter Lee
- Address
- 970 Woodlands Pkwy
- City
- Indian Creek
- State
- IL
- ZIP
- 60061
- Country
- US
- [email protected]
- Phone
- 714 6134338
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2022-09-14 |
| Full Field Digital, System, X-Ray, Mammographic | MUE | Class 2 | Radiology | No | 2025-01-17 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2026-04-02 |
Proprietary Names
VIVIX-S 4386W
Cuattro ONE
L8643-AWV
Saturn 8000
VIVIX-S F series
F3025-AW
VIVIX-S FW
VIVIX-S 1717V
VIVIX-M
VXvue
VIVIX-S 1717N
ViVIX-S Wireless
PRO 3543
PRO 3543C
QXLink
PRO 3543T
PRO 3543TC
PRO 4343FC
PRO 4343F
ViVIX-S
FXRD-1417N
FXRD-1751SA
FXRD-1751SB
VIVIX-S 1751S
Cuattro ONE Long Format Digital Radiography
Carestream DRX-L Detector
VWD-1012P
VWD-1417A
VIVIX-S VW
S3025-AW
XD 14
XD+10
XD 17
XD+17
XD+14
XD 10
S3025-AWM
VIVIX-S V series
VWD-1417P
VWD-1717A
RXsensor
VWD-1717P
VWD-1012A
VIVIX-S 1012N
Establishment Types
Manufacture Medical Device