The following data is part of a premarket notification filed by Eizo Corporation with the FDA for Radiforce Mx194.
| Device ID | K180961 |
| 510k Number | K180961 |
| Device Name: | RadiForce MX194 |
| 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 | 2018-04-12 |
| Decision Date | 2018-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04995047052777 | K180961 | 000 |
| 04995047058625 | K180961 | 000 |