The following data is part of a premarket notification filed by Medical Intelligence Medizintechnik-gmbh-an Elekta with the FDA for Iguide System.
| Device ID | K072079 |
| 510k Number | K072079 |
| Device Name: | IGUIDE SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA FEYERABENDSTRASSE 13-15 Schwabmunchen, DE 86830 |
| Contact | Michael Wolff |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-07-30 |
| Decision Date | 2007-08-14 |
| Summary: | summary |