The following data is part of a premarket notification filed by Ge Dec Medical Systems with the FDA for Uroview Systems Tomography Option Software.
| Device ID | K936136 |
| 510k Number | K936136 |
| Device Name: | UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Contact | Robert Odell |
| Correspondent | Robert Odell GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-22 |
| Decision Date | 1994-01-25 |