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 |