Clearance Summary
SIS-300(N)-DIA SCAN received FDA 510(k) clearance under submission number K926434, sponsored by Micro-Focus Imaging., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1993-03-18.
- Submission: K926434
- Applicant / Sponsor: Micro-Focus Imaging., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1993-03-18
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.