Atlas FDA

VARIS 1.4G

FDA 510(k) clearance K001643 · decided 2000-06-23

Clearance details

K-number
K001643
Device name
VARIS 1.4G
Applicant
Varian Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2000-05-30
Decision date
2000-06-23
Days to decision
24 days
Clearance type
Special
Product code
IYE
Device class
2
Regulation number
892.5050
Medical specialty
Radiology
Advisory committee
Radiology
Location
Palo Alto, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy. recall (Z-1957-2011)Varian Medical Systems, Inc. Oncology Systems2011-04-12
VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Manufactured by Var recall (Z-0133-2010)Varian Medical Systems Oncology Systems2009-11-09
Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFS recall (Z-1809-2009)Varian Medical Systems Oncology Systems2009-08-27
Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; M recall (Z-0164-2009)Varian Medical Systems Oncology Systems2008-10-22
Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Al recall (Z-2194-2008)Varian Medical Systems Oncology Systems2008-09-04
Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Ver recall (Z-0720-2008)Varian Medical Systems Inc2008-02-15
4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy recall (Z-0304-2007)Varian Medical Systems Inc2006-12-19
VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2. recall (Z-0633-03)Varian Medical Systems Inc2003-03-12