Clearance Summary
ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 received FDA 510(k) clearance under submission number K071673, sponsored by Onc Solutions, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2007-07-18.
- Submission: K071673
- Applicant / Sponsor: Onc Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2007-07-18
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.