The following data is part of a premarket notification filed by Mitsubishi Heavy Industries, Ltd. with the FDA for Mhi-tm2000 Linear Accelerator System Vero Imavis.
| Device ID | K122450 |
| 510k Number | K122450 |
| Device Name: | MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS |
| Classification | Accelerator, Linear, Medical |
| Applicant | MITSUBISHI HEAVY INDUSTRIES, LTD. 4-6-22 KAN-ON-SHIN-MACHI NISHI-KU Hiroshima-shi, JP 733-8553 |
| Contact | Yoichi Wakiyama |
| Correspondent | Yoichi Wakiyama MITSUBISHI HEAVY INDUSTRIES, LTD. 4-6-22 KAN-ON-SHIN-MACHI NISHI-KU Hiroshima-shi, JP 733-8553 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-13 |
| Decision Date | 2012-10-03 |
| Summary: | summary |