IGUIDE SYSTEM— 510(k) K072079
Substantially EquivalentMedical Intelligence Medizintechnik-GmbH-An Elekta
FDA 510(k) clearance K072079 for IGUIDE SYSTEM, Substantially Equivalent on 2007-08-14. Applicant: Medical Intelligence Medizintechnik-GmbH-An Elekta. Device class: 2.
Clearance details
- Applicant
- Medical Intelligence Medizintechnik-GmbH-An Elekta
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Schwabmunchen, DE
Recent devices under product code IYE
view allMore clearances from Medical Intelligence Medizintechnik-GmbH-An Elekta
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K072079
K-number listed on FDA's recall record- Z-2082-2019 — 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 Tracking System in a radiotherapy environment.
- Z-2230-2019 — iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
- Z-2691-2016 — 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.
- Z-1705-2016 — iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
- Z-1807-2014 — 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072079.
Data sourced from openFDA. This site is unofficial and independent of the FDA.