Clearance Summary
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) received FDA 510(k) clearance under submission number K965161, sponsored by Sectra-Imtec AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-03-12.
- Submission: K965161
- Applicant / Sponsor: Sectra-Imtec AB
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2020
- Decision date: 1997-03-12
Classification & Regulation
This clearance is catalogued under FDA product code LMD and 21 CFR 892.2020, within the Radiology review panel as a Class I device.