# K152867: MHI-TM2000 Linear Accelerator System, VERO, Imavis

- Pathway: 510(k) (Special)
- Applicant: Mitsubishi Heavy Industries, Ltd.
- Decided: Oct 21, 2015 after 21 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K072047 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122450: Mhi-TM2000 Linear Accelerator System Vero Imavis, Mitsubishi Heavy Industries, Ltd. (2012) Summary page 4.

## Recalls of this device
- Dec 8, 2017 · Class II · Z-1585-2018: Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
- Mar 7, 2016 · Class II · Z-1308-2016: In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met. If Gantry angle for the first bea
- Dec 15, 2015 · Class II · Z-1244-2016: Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under specific conditi

## Indications for use
MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

Source page: https://510kreport.com/device/K152867
Methodology: https://510kreport.com/methodology