The following data is part of a premarket notification filed by Vision Rt Limited with the FDA for Gatect-rt.
| Device ID | K072171 |
| 510k Number | K072171 |
| Device Name: | GATECT-RT |
| Classification | Accelerator, Linear, Medical |
| Applicant | VISION RT LIMITED 1244 FAIRWAY VALLEY COURT Lincoln, CA 95648 |
| Contact | Robert J Morton, M.s. |
| Correspondent | Robert J Morton, M.s. VISION RT LIMITED 1244 FAIRWAY VALLEY COURT Lincoln, CA 95648 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-06 |
| Decision Date | 2007-10-01 |
| Summary: | summary |