Clearance Summary
WISE (II) IMAGE MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number K983447, 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 1998-10-29.
- Submission: K983447
- Applicant / Sponsor: Sectra-Imtec AB
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2010
- Decision date: 1998-10-29
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.