PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING— 510(k) K003936
Substantially EquivalentTomtec Imaging Systems GmbH
FDA 510(k) clearance K003936 for PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING, Substantially Equivalent on 2001-02-14. Applicant: Tomtec Imaging Systems GmbH.
Clearance details
- Applicant
- Tomtec Imaging Systems GmbH
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Unterschleissheim, DE
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.