The following data is part of a premarket notification filed by Eizo Corporation with the FDA for Radiforce Rx560, Rx560-ar.
| Device ID | K172738 |
| 510k Number | K172738 |
| Device Name: | RadiForce RX560, RX560-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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-12 |
| Decision Date | 2017-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14995047051449 | K172738 | 000 |
| 04995047051428 | K172738 | 000 |
| 14995047051401 | K172738 | 000 |
| 04995047051381 | K172738 | 000 |
| 14995047059582 | K172738 | 000 |
| 04995047059530 | K172738 | 000 |
| 14995047059483 | K172738 | 000 |
| 04995047059431 | K172738 | 000 |