The following data is part of a premarket notification filed by Eizo Corporation with the FDA for Radiforce Rx1270, Radiforce Rx1270-ar.
| Device ID | K200485 |
| 510k Number | K200485 |
| Device Name: | RadiForce RX1270, RadiForce RX1270-AR |
| Classification | Display, Diagnostic Radiology |
| Applicant | EIZO Corporation 153 Shimokashiwano Hakusan, JP 924-8566 |
| Contact | Hiroaki Hashimoto |
| Correspondent | Hiroaki Hashimoto EIZO Corporation 153 Shimokashiwano Hakusan, JP 924-8566 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-27 |
| Decision Date | 2020-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04995047055600 | K200485 | 000 |
| 04995047055587 | K200485 | 000 |
| 04995047058366 | K200485 | 000 |
| 04995047058359 | K200485 | 000 |