SCENARIA View
System, X-ray, Tomography, Computed
Hitachi Healthcare Americas
The following data is part of a premarket notification filed by Hitachi Healthcare Americas with the FDA for Scenaria View.
Pre-market Notification Details
| Device ID | K190841 |
| 510k Number | K190841 |
| 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 | 2019-04-01 |
| Decision Date | 2019-09-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04580292766694 | K190841 | 000 |
| 04573596200544 | K190841 | 000 |
Trademark Results [SCENARIA View]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCENARIA VIEW 87543618 5625205 Live/Registered |
KABUSHIKI KAISHA HITACHI SEISAKUSHO 2017-07-26 |
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