Clearance Summary
ADVANCED TREATMENT PLANNING SYSTEM received FDA 510(k) clearance under submission number K972816, sponsored by Advanced Radiation Therapy Systems, 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 1998-01-23.
- Submission: K972816
- Applicant / Sponsor: Advanced Radiation Therapy Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1998-01-23
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.