IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0— 510(k) K082510
Substantially EquivalentTomtec Imaging Systems GmbH
FDA 510(k) clearance K082510 for IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0, Substantially Equivalent on 2008-10-01. Applicant: Tomtec Imaging Systems GmbH. Device class: 2.
Clearance details
- Applicant
- Tomtec Imaging Systems GmbH
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Unterschleissheim, DE
Recent devices under product code LLZ
view allMore clearances from Tomtec Imaging Systems GmbH
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.