510(k) K072079 ยท IYE Accelerator, Linear, Medical
IGUIDE SYSTEM
| Applicant | Medical Intelligence Medizintechnik-GmbH-An Elekta, Schwabmunchen, DE |
| Decision | Substantially Equivalent, Aug 14, 2007 |
| Received | Jul 30, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072079
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2019 | Medical Intelligence Medizintechnik Gmbh IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2
Product Usage:
Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Trackin Terminated |
IYE | None listed |
| Jun 19, 2019 | Elekta, Inc. iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 Terminated |
IYE | None listed |
| Aug 30, 2016 | Elekta, Inc. HexaPOD evo RT System
Product Usage:
The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment. Terminated |
IYE | None listed |
| May 23, 2016 | Elekta, Inc. iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment. Terminated |
IYE | None listed |
| Jun 17, 2014 | Elekta, Inc. iGUIDE System
Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.