Clearance Summary
SHARP VIEW IMAGE ENHANCEMENT SYSTEM received FDA 510(k) clearance under submission number K024028, sponsored by Context Vision 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 2003-01-24.
- Submission: K024028
- Applicant / Sponsor: Context Vision AB
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2003-01-24
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.