The following data is part of a premarket notification filed by Eizo Corporation with the FDA for 3mp Color Lcd Monitor, Radiforce Rx350.
| Device ID | K153354 |
| 510k Number | K153354 |
| Device Name: | 3MP Color LCD Monitor, RadiForce RX350 |
| 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 | 2015-11-20 |
| Decision Date | 2016-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04995047047261 | K153354 | 000 |
| 04995047047247 | K153354 | 000 |