Clearance Summary
PACENTRIC CONNECT, TRAVELER AND WEB received FDA 510(k) clearance under submission number K100837, sponsored by Fimreite Software AS. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-12-03.
- Submission: K100837
- Applicant / Sponsor: Fimreite Software AS
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2010-12-03
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.