Clearance Summary
XPLAN 2.2 WITH THE BODY SYSTEM received FDA 510(k) clearance under submission number K013661, sponsored by Radionics, A Division of Tyco Healthcare Group LP. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-12-03.
- Submission: K013661
- Applicant / Sponsor: Radionics, A Division of Tyco Healthcare Group LP
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2001-12-03
Classification & Regulation
This clearance is catalogued under FDA product code MUJ and 21 CFR 892.5050, within the Radiology review panel as a Class II device.