Clearance Summary
TRS 2000 TELERADIOLOGY SYSTEM received FDA 510(k) clearance under submission number K961983, 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 1996-08-13.
- Submission: K961983
- Applicant / Sponsor: Sectra-Imtec AB
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1996-08-13
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.