The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Kxo-80g.
| Device ID | K945668 |
| 510k Number | K945668 |
| Device Name: | KXO-80G |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Javad Seyedzadeh |
| Correspondent | Javad Seyedzadeh TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-17 |
| Decision Date | 1994-12-27 |