Clearance Summary
SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 received FDA 510(k) clearance under submission number K081469, sponsored by Sectra Imtec AB. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-06-12.
- Submission: K081469
- Applicant / Sponsor: Sectra Imtec AB
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2008-06-12
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.