510(k) · Cleared
Recalled · Class II · 2017MHI-TM2000 Linear Accelerator System, VERO, Imavis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitsubishi Heavy Industries, Ltd. · IYE Accelerator, Linear, Medical
Cleared on Oct 21, 2015 as substantially equivalent to K122450 (Mitsubishi Heavy Industries, Ltd., 2012) after a 21-day review. Its family tree reaches back 2 generations to 2007. It has been recalled 3 times.
- Decided
- Oct 21, 2015
- Review
- 21 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K072047 (2007). No later device cites it as a predicate yet.
- Root · 2 generations backK072047 Mhi-TM2000 Linear Accelerator SystemMitsubishi Heavy Industries, Ltd. · 2007 · Recalled
- 1 generation backK122450 Mhi-TM2000 Linear Accelerator System Vero ImavisMitsubishi Heavy Industries, Ltd. · 2012 · Recalled
- This deviceK152867 MHI-TM2000 Linear Accelerator System, VERO, ImavisMitsubishi Heavy Industries, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K072047 | Mhi-TM2000 Linear Accelerator System | Mitsubishi Heavy Industries, Ltd. | 2007 | 7 |
| −1 | K122450 | Mhi-TM2000 Linear Accelerator System Vero Imavis | Mitsubishi Heavy Industries, Ltd. | 2012 | 7 |
| 0 (this device) | K152867 | MHI-TM2000 Linear Accelerator System, VERO, Imavis | Mitsubishi Heavy Industries, Ltd. | 2015 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122450 | Mhi-TM2000 Linear Accelerator System Vero ImavisSummary page 4…892.5050, Class II Product Code: IYE 3. Predicate devices to claim substantial equivalence: MHI-TM2000 Linear Accelerator System: K122450 4. Description of the Device: The MHI-TM2000 Linear Accelerator System (hereinafter called "MHI-TM2000 (Ver. 3.5)") is an… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 8, 2017 | Class II | Z-1585-2018 | Device Design | 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 | Software design | 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 beam of IMRT is incorrectly set and if… |
| Dec 15, 2015 | Class II | Z-1244-2016 | Software design | 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 conditions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 5.1 years on median.
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152867: MHI-TM2000 Linear Accelerator System, VERO, Imavis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152867
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026