The following data is part of a premarket notification filed by Eizo Corporation with the FDA for Radiforce Gx560, Gx560-ar.
| Device ID | K181609 |
| 510k Number | K181609 |
| Device Name: | RadiForce GX560, GX560-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 | 2018-06-19 |
| Decision Date | 2018-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04995047054108 | K181609 | 000 |
| 04995047059165 | K181609 | 000 |
| 04995047059219 | K181609 | 000 |
| 14995047059261 | K181609 | 000 |
| 14995047059292 | K181609 | 000 |
| 04995047053194 | K181609 | 000 |
| 04995047053217 | K181609 | 000 |
| 04995047053231 | K181609 | 000 |
| 14995047053252 | K181609 | 000 |
| 04995047059110 | K181609 | 000 |