The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Toshiba Rtp9211j-g11, J-advanced Image Intensifier (i.i.).
| Device ID | K993038 |
| 510k Number | K993038 |
| Device Name: | TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) |
| 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 | Diana Thorson |
| Correspondent | Diana Thorson 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 | 1999-09-10 |
| Decision Date | 1999-10-07 |
| Summary: | summary |