Clearance Summary
MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY received FDA 510(k) clearance under submission number K091403, sponsored by Oncology Tech, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-07-29.
- Submission: K091403
- Applicant / Sponsor: Oncology Tech, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5710
- Decision date: 2009-07-29
Classification & Regulation
This clearance is catalogued under FDA product code IXI and 21 CFR 892.5710, within the Radiology review panel as a Class II device.