Clearance Summary
TELEPAX received FDA 510(k) clearance under submission number K011173, sponsored by Imed Systems & Consulting, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-07-11.
- Submission: K011173
- Applicant / Sponsor: Imed Systems & Consulting, LLC
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2001-07-11
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.