The following data is part of a premarket notification filed by Toshiba Medical Systems with the FDA for Bla-800a.
| Device ID | K954310 |
| 510k Number | K954310 |
| Device Name: | BLA-800A |
| Classification | Device, Beam Limiting, X-ray, Diagnostic |
| Applicant | TOSHIBA MEDICAL SYSTEMS 2441 MICHELLE P.O. BOX 2068 Tustin, CA 92680 |
| Contact | Javad Seyedzadeh |
| Correspondent | Javad Seyedzadeh TOSHIBA MEDICAL SYSTEMS 2441 MICHELLE P.O. BOX 2068 Tustin, CA 92680 |
| Product Code | KPW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-15 |
| Decision Date | 1995-10-18 |