The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Tosbee.
| Device ID | K914583 | 
| 510k Number | K914583 | 
| Device Name: | TOSBEE | 
| Classification | Generator, Low Voltage, Therapeutic X-ray | 
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 | 
| Contact | Timothy W Capehart | 
| Correspondent | Timothy W Capehart TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 | 
| Product Code | IYD | 
| CFR Regulation Number | 892.5900 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1991-10-16 | 
| Decision Date | 1993-01-28 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  TOSBEE  74125357  1855647 Dead/Cancelled | Kabushiki Kaisha Toshiba 1990-12-21 |