510(k) K200485
- Device
- RadiForce RX1270, RadiForce RX1270-AR
- Applicant
- EIZO Corporation
- 510(k) number
- K200485
- Product code
- PGY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-03-23
- Date received
- 2020-02-27
- Regulation
- 892.2050
- Classification name
- Display, Diagnostic Radiology
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Hiroaki Hashimoto
- Address
- 153 Shimokashiwano Hakusan JP 924-8566 924-8566
FDA Registration Numbers#
- 3013084615
- 3007817002
- 3008481104
- 3031232523
- 9613188
- 3013501671
- 3006615210
- 3024137003
- 3024689474
- 3024897454
- 3015976667
- 3010043098
- 1000207387
- 3003032840
- 3009553444
- 3004434200
- 3000237660
- 3002808157
- 3004082357
- 3016696283
- 1000181154
Source Documents#
Other 510(k) Records For Product Code PGY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252780 | LCD Monitor (CL1902A, CL2103F) | Shenzhen Beacon Display Technology Co., Ltd. | 2025-12-19 |
| K253242 | LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. | 2025-10-29 |
| K252030 | RadiForce GX570; RadiForce GX570-AR | Eizo Corporation | 2025-08-28 |
| K243221 | RadiForce RX570; RadiForce RX570-AR | Eizo Corporation | 2024-11-27 |
| K243031 | LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. | 2024-10-25 |
| K242008 | Coronis OneLook | Barco N.V. | 2024-08-02 |
| K241105 | 3MP Color LCD Monitor (CL-S301) | Jvckenwood Corporation | 2024-08-01 |
| K241441 | RadiForce RX670; RadiForce RX670-AR | Eizo Corporation | 2024-07-16 |
| K241499 | 21.3” 5MP Color LCD Display UMD5-21B01 | Acula Technology Corp. | 2024-06-13 |
| K233336 | 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) | Acula Technology Corp. | 2024-05-21 |
| K240310 | LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. | 2024-03-29 |
| K240130 | Medical Monitor (21HQ613D) | Lg Electronics.Inc | 2024-02-15 |
| K233897 | 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) | Shenzhen Beacon Display Technology Co., Ltd. | 2024-02-06 |
| K233465 | RadiForce MX317W | Eizo Corporation | 2023-12-21 |
| K232985 | 24HR513C | Lg Electronics.Inc | 2023-12-11 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases