The following data is part of a premarket notification filed by Eizo Corporation with the FDA for 5mp Monochrome Lcd Monitor, Radiforce Gx550, Gx550-ar.
| Device ID | K162497 |
| 510k Number | K162497 |
| Device Name: | 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-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 | 2016-09-07 |
| Decision Date | 2016-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14995047048302 | K162497 | 000 |
| 04995047048282 | K162497 | 000 |
| 14995047048265 | K162497 | 000 |
| 04995047048244 | K162497 | 000 |