Clearance Summary
MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) received FDA 510(k) clearance under submission number K012289, sponsored by Elekta Oncology Systems, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-08-14.
- Submission: K012289
- Applicant / Sponsor: Elekta Oncology Systems, Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2001-08-14
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.