Sirius Starmobile Tiara
System, X-ray, Mobile
HITACHI MEDICAL SYSTEMS AMERICA, INC.
The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Sirius Starmobile Tiara.
Pre-market Notification Details
| Device ID | K143537 |
| 510k Number | K143537 |
| Device Name: | Sirius Starmobile Tiara |
| Classification | System, X-ray, Mobile |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Contact | Doug Thistlewaite |
| Correspondent | Doug Thistlewaite HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-15 |
| Decision Date | 2015-03-06 |
| Summary: | summary |
Trademark Results [Sirius Starmobile Tiara]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIRIUS STARMOBILE TIARA 86490078 not registered Dead/Abandoned |
KABUSHIKI KAISHA HITACHI SEISAKUSHO 2014-12-24 |
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