The following data is part of a premarket notification filed by Hitachi Healthcare Americas with the FDA for Scenaria View.
| Device ID | K200498 |
| 510k Number | K200498 |
| Device Name: | SCENARIA View |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Contact | Aaron Pierce |
| Correspondent | Aaron Pierce Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-28 |
| Decision Date | 2020-07-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SCENARIA VIEW 87543618 5625205 Live/Registered |
KABUSHIKI KAISHA HITACHI SEISAKUSHO 2017-07-26 |