MHI-TM2000 LINEAR ACCELERATOR SYSTEM— 510(k) K072047
Substantially EquivalentMitsubishi Heavy Industries, Ltd.
FDA 510(k) clearance K072047 for MHI-TM2000 LINEAR ACCELERATOR SYSTEM, Substantially Equivalent on 2007-08-29. Applicant: Mitsubishi Heavy Industries, Ltd.. Device class: 2.
Clearance details
- Applicant
- Mitsubishi Heavy Industries, Ltd.
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hiroshima-Shi, JP
Recent devices under product code IYE
view allMore clearances from Mitsubishi Heavy Industries, Ltd.
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K072047
K-number listed on FDA's recall record- Z-1585-2018 — 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 treatment is indicated.
- Z-1308-2016 — 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 in the body where radiation treatment is indicated.
- Z-1244-2016 — 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.
- Z-1574-2015 — MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
- Z-0821-2015 — VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
- Z-2653-2014 — VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
- Z-1931-2013 — MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072047.
Data sourced from openFDA. This site is unofficial and independent of the FDA.