Clearance Summary
IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM received FDA 510(k) clearance under submission number K963395, 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 1996-10-25.
- Submission: K963395
- Applicant / Sponsor: Sectra-Imtec AB
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2010
- Decision date: 1996-10-25
Classification & Regulation
This clearance is catalogued under FDA product code LMB and 21 CFR 892.2010, within the Radiology review panel as a Class I device.