Atlas FDA

ECLIPSE TREATMENT PLANNING SYSTEM

FDA 510(k) clearance K073020 · decided 2007-12-19

Clearance details

K-number
K073020
Device name
ECLIPSE TREATMENT PLANNING SYSTEM
Applicant
Varian Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2007-10-26
Decision date
2007-12-19
Days to decision
54 days
Clearance type
Special
Product code
MUJ
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
Eclipse Treatment Planning System, 4D Structure Merge Tool Option in Eclipse Release 8.5 - recall (Z-3022-2011)Varian Medical Systems, Inc. Oncology Systems2011-08-15
Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Product Usage: Ec recall (Z-3002-2011)Varian Medical Systems, Inc. Oncology Systems2011-08-11
Eclipse Treatment Planning System; Release 6.5 through 10 (build 7.3.10 through 10.0.34) V recall (Z-2780-2011)Varian Medical Systems, Inc. Oncology Systems2011-07-11
Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc.. recall (Z-2702-2011)Varian Medical Systems, Inc. Oncology Systems2011-06-29
Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; Model Number: recall (Z-2220-2011)Varian Medical Systems, Inc. Oncology Systems2011-05-19
Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3 (bui recall (Z-1412-2010)Varian Medical Systems Oncology Systems2010-04-20