Clearance Summary
MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 received FDA 510(k) clearance under submission number K033712, 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 2003-12-23.
- Submission: K033712
- Applicant / Sponsor: Sectra-Imtec AB
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2003-12-23
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.