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.
Clearance details
- Applicant
- Medical Intelligence Medizintechnik-GmbH-An Elekta
- Product code
- Code IYE
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Schwabmunchen, DE
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.