The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Ecg-gating System For Aquilion Ct Scanner, Tsx-101a.
| Device ID | K991766 |
| 510k Number | K991766 |
| Device Name: | ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-24 |
| Decision Date | 1999-08-10 |
| Summary: | summary |