The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Max-1000a/r1.
| Device ID | K954590 |
| 510k Number | K954590 |
| Device Name: | MAX-1000A/R1 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Javad Seuedzadeh |
| Correspondent | Javad Seuedzadeh TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1995-11-20 |