SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2— 510(k) K081469
Substantially EquivalentSectra Imtec AB
FDA 510(k) clearance K081469 for SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2, Substantially Equivalent on 2008-06-12. Applicant: Sectra Imtec AB.
Clearance details
- Applicant
- Sectra Imtec AB
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Denton, TX, US
Adverse 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.