510(k) K152867 ยท IYE Accelerator, Linear, Medical
MHI-TM2000 Linear Accelerator System, VERO, Imavis
| Applicant | Mitsubishi Heavy Industries, Ltd., Hiroshima-Shi, JP |
| Decision | Substantially Equivalent, Oct 21, 2015 |
| Received | Sep 30, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152867
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2017 | Hitachi Ltd., Medical System Operations Group MHI-TM2000 Linear Accelerator System
Product Usage:
MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treat Terminated |
IYE | None listed |
| Mar 31, 2016 | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator
MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere Terminated |
IYE | None listed |
| Mar 24, 2016 | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after)
Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.