Clearance Summary
DIFFUSER PANEL received FDA 510(k) clearance under submission number K970240, sponsored by Focused Viewer, 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 1997-03-11.
- Submission: K970240
- Applicant / Sponsor: Focused Viewer, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1890
- Decision date: 1997-03-11
Classification & Regulation
This clearance is catalogued under FDA product code IXC and 21 CFR 892.1890, within the Radiology review panel as a Class I device.