Atlas FDA

MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS

FDA 510(k) clearance K122450 · decided 2012-10-03

Clearance details

K-number
K122450
Device name
MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS
Applicant
Mitsubishi Heavy Industries, Ltd.
Decision
Substantially Equivalent
Date received
2012-08-13
Decision date
2012-10-03
Days to decision
51 days
Clearance type
Traditional
Product code
IYE
Device class
2
Regulation number
892.5050
Medical specialty
Radiology
Advisory committee
Radiology
Location
Hiroshima-Shi, JP
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI- recall (Z-1308-2016)MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK2016-03-31
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radia recall (Z-1244-2016)MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK2016-03-24
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) recall (Z-1574-2015)MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK2015-05-01
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Softwa recall (Z-0821-2015)MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK2014-12-17
VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accel recall (Z-2653-2014)MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK2014-09-16
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Propr recall (Z-1931-2013)MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK2013-08-08