VANTAGE ELAN
System, Nuclear Magnetic Resonance Imaging
TOSHIBA AMERICA MEDICAL SYSTEMS INC
The following data is part of a premarket notification filed by Toshiba America Medical Systems Inc with the FDA for Vantage Elan.
Pre-market Notification Details
| Device ID | K141472 |
| 510k Number | K141472 |
| Device Name: | VANTAGE ELAN |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS INC 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA AMERICA MEDICAL SYSTEMS INC 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-03 |
| Decision Date | 2014-09-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670101632 | K141472 | 000 |
| 04987670101540 | K141472 | 000 |
| 04987670101519 | K141472 | 000 |
Trademark Results [VANTAGE ELAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VANTAGE ELAN 79150061 4643194 Live/Registered |
Canon Medical Systems Corporation 2014-04-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.