Clearance Summary
MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM received FDA 510(k) clearance under submission number K002936, 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 2000-10-17.
- Submission: K002936
- Applicant / Sponsor: Sectra-Imtec AB
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2000-10-17
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.