KALARE
System, X-ray, Fluoroscopic, Image-intensified
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 Kalare.
Pre-market Notification Details
| Device ID | K133553 |
| 510k Number | K133553 |
| Device Name: | KALARE |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92780 -2068 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92780 -2068 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-19 |
| Decision Date | 2014-06-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670101809 | K133553 | 000 |
| 04987670101670 | K133553 | 000 |
| 04987670100369 | K133553 | 000 |
| 04987670100116 | K133553 | 000 |
| 00840682120982 | K133553 | 000 |
Trademark Results [KALARE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KALARE 98193157 not registered Live/Pending |
Carsaro & Associates, LLC 2023-09-22 |
 KALARE 76606338 3033674 Live/Registered |
CANON MEDICAL SYSTEMS CORPORATION 2004-08-10 |
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