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 3, 2012 as substantially equivalent to K072047 (Mitsubishi Heavy Industries, Ltd., 2007) after a 51-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Oct 3, 2012
- Review
- 51 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072047 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK072047 Mhi-TM2000 Linear Accelerator SystemMitsubishi Heavy Industries, Ltd. · 2007 · Recalled
- This deviceK122450 Mhi-TM2000 Linear Accelerator System Vero ImavisMitsubishi Heavy Industries, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK152867 MHI-TM2000 Linear Accelerator System, VERO, ImavisMitsubishi Heavy Industries, Ltd. · 2015 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K152867MHI-TM2000 Linear Accelerator System, VERO, ImavisMitsubishi Heavy Industries, Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072047 | Mhi-TM2000 Linear Accelerator System | Mitsubishi Heavy Industries, Ltd. | 2007 | 7 |
| 0 (this device) | K122450 | Mhi-TM2000 Linear Accelerator System Vero Imavis | Mitsubishi Heavy Industries, Ltd. | 2012 | — |
| +1 | K152867 | MHI-TM2000 Linear Accelerator System, VERO, Imavis | Mitsubishi Heavy Industries, Ltd. | 2015 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
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 |
|---|---|---|---|
| * | K072047 | Mhi-TM2000 Linear Accelerator SystemSummary page 1…uct Code: lYE 3. Predicate devices to claim substantial equivalence: 1). Mitsubishi Heavy Industries, Ltd. MHI-TM2000 Linear Accelerator System - K072047 Section 5: 510(k) Summary 113… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152867 | MHI-TM2000 Linear Accelerator System, VERO, Imavis | 2015 | 0 |
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. |
| Apr 17, 2015 | Class II | Z-1574-2015 | Software design (manufacturing process) | The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered radiation record)… |
| Dec 2, 2014 | Class II | Z-0821-2015 | Software design | Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result, ExacTrac may display a… |
| Jul 5, 2014 | Class II | Z-2653-2014 | Software design | Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become Treated (completed) status on the exact day… |
| Jun 21, 2013 | Class II | Z-1931-2013 | Software Design Change | Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K152867 (Mitsubishi Heavy Industries, Ltd., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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/K122450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122450: 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/K122450
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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