Clearance Summary
DEXIS Webview received FDA 510(k) clearance under submission number K151941, sponsored by Imaging Sciences International /Gendex/Dexis. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2015-10-07.
- Submission: K151941
- Applicant / Sponsor: Imaging Sciences International /Gendex/Dexis
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2015-10-07
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.