FDA Registration
Active
🇯🇵 Japan
EIZO CORPORATION
Reg #: 3000237660
·
FEI: 3000237660
·
Expires 2026
Products
7
Proprietary Names
75
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- EIZO CORPORATION
- Registration Number
- 3000237660
- FEI Number
- 3000237660
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 153 SHIMOKASHIWANO
- City
- HAKUSAN Ishikawa
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K143261
Owner / Operator
- Firm Name
- EIZO Corporation
- Operator Number
- 9085040
- Address
- 153 Shimokashiwano
- City
- Hakusan
- State
- Ishikawa
- Postal Code
- 924-8566
- Country
- JP
US Agent
- Business Name
- EIZO Inc.
- Contact Name
- THOMAS WALETZKI
- Address
- 5710 Warland DR
- City
- Cypress
- State
- CA
- ZIP
- 90630
- Country
- US
- [email protected]
- Phone
- 562 4315011
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2014-10-09 |
| Display, Diagnostic Radiology | PGY | Class 2 | Radiology | No | 2014-12-11 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2009-08-27 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2012-05-01 |
| Instrument, Quality-Assurance, Radiologic | LHO | Class 1 | Radiology | No | 2024-10-30 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-12-19 |
| Device, Digital Image Storage, Radiological | LMB | Class 1 | Radiology | No | 2024-08-22 |
Proprietary Names
1MP Color LCD Monitor, RadiForce MX192
1MP Color LCD Monitor, RadiForce MX192-F
EA720-F
RadiForce MS236WT-L
EA720
RadiForce MS236WT-F
RadiForce MX193
RadiForce MX191
RadiForce MX195
RadiForce MS236WT-A
2.3MP Color LCD Monitor, RadiForce MX242W
RadiForce MX315W
RadiForce RX560-AR
RadiForce RX560
EX3140
CuratOR EX2620
CuratOR EX2620-3D (with 3D glasses H3G01 or H3G02)
EX2620-3D (with 3D glasses H3G01 or H3G02)
EX3141
CuratOR EX2621
EX3220-3D (with 3D glasses H3G01 or H3G02)
CuratOR EX3140
EX2721
CuratOR EX3220-3D (with 3D glasses H3G01 or H3G02)
CuratOR EX3220
CuratOR EX2721
CuratOR EX3141-3D (with 3D glasses H3G01 or H3G02)
TM343
CuratOR EX3241
CuratOR EX3242-3D (with 3D glasses H3G01 or H3G02)
CuratOR EX3242
TM344
CuratOR EX2722
TM351 (with 3D glasses H3G01 or H3G02)
8MP Color LCD Monitor, RadiForce RX850-AR
8MP Color LCD Monitor, RadiForce RX850
2MP Monochrome LCD Monitor, RadiForce GX240
3MP Monochrome LCD Monitor, RadiForce GX340
Monochrome LCD Monitor, RadiForce GS220
RadiForce RX570
RadiForce RX570-AR
RadiForce MX217
4MP Color LCD Monitor, RadiForce RX440
2MP Color LCD Monitor, RadiForce RX250
2MP Color LCD Monitor, RadiForce RX250-AR
RadiForce RX660-AR
RadiForce RX660
Color LCD Monitor, RadiForce RS110
RadiForce MX243W
RadiForce RX1270
RadiForce RX1270-AR
RadiCS
CuratOR EX3242-FD
2MP Color LCD Monitor, RadiForce MX215
2MP Color LCD Monitor, RadiForce MX215-X
RadiForce GX560
RadiForce GX560-AR
RadiForce RX370
RadiForce RX370-AR
RadiForce GX570
RadiForce GX570-AR
CuratOR MIR-1
3MP Color LCD Monitor, RadiForce RX350-AR
3MP Color LCD Monitor, RadiForce RX350
RadiForce RX360
RadiForce RX360-AR
RadiForce RX270
RadiForce RX270-AR
RadiForce MX194
RadiForce RX670
RadiForce RX670-AR
RadiForce MX216
RadiForce MX317W
5MP Monochrome LCD Monitor, RadiForce GX550
5MP Monochrome LCD Monitor, RadiForce GX550-AR
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility