Clearance Summary
MHI-TM2000 Linear Accelerator System, VERO, Imavis received FDA 510(k) clearance under submission number K152867, sponsored by Mitsubishi Heavy Industries, 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 2015-10-21.
- Submission: K152867
- Applicant / Sponsor: Mitsubishi Heavy Industries, Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2015-10-21
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.