The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Angiorex Cat-350b.
| Device ID | K951053 |
| 510k Number | K951053 |
| Device Name: | ANGIOREX CAT-350B |
| Classification | Table, Radiographic, Non-tilting, Powered |
| 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 | IZZ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-07 |
| Decision Date | 1995-04-06 |