Clearance Summary
.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR received FDA 510(k) clearance under submission number K040804, sponsored by Southeastern Radiation Products, 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 2004-04-28.
- Submission: K040804
- Applicant / Sponsor: Southeastern Radiation Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5710
- Decision date: 2004-04-28
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.