510(k) K142434

Device
ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
510(k) number
K142434
Product code
IYE  
Decision
Substantially Equivalent (SESE)
Decision date
2014-11-21
Date received
2014-08-29
Regulation
892.5050
Classification name
Accelerator, Linear, Medical
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
CHRISTINE DUNBAR
Address
757 "A" Arnold Dr. Martinez CA US 94553 94553

FDA Registration Numbers

Source Documents

510(k) summary PDF

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Legacy Summary

summary

FDA Review

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