The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Positron Option, Model Nsco-050a.
| Device ID | K983514 |
| 510k Number | K983514 |
| Device Name: | POSITRON OPTION, MODEL NSCO-050A |
| Classification | System, Tomography, Computed, Emission |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Donnelle Krajewski |
| Correspondent | Donnelle Krajewski TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-07 |
| Decision Date | 1998-12-23 |
| Summary: | summary |