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Standard Imaging, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K103193DOSEVIEW 3DDecember 27, 2010
K082773STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331November 19, 2008
K060532HDR 1000 PLUS WELL CHAMBER, MODEL 90008April 11, 2006
K042733STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEMNovember 15, 2004
K040688STANDARD IMAGING E.IMRT CALCULATORMay 11, 2004
K013548STANDARD IMAGING IVB 1000 WELL CHAMBERNovember 9, 2001
K002833MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBERSeptember 28, 2000
K001825STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBERAugust 2, 2000
K940539STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORMMarch 16, 1994
K922554STANDARD IMAGING HDR 1000 ION CHAMBERAugust 24, 1992