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superDimension, Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2001-2012Class IIsuperDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displayinJune 18, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K120796SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKEROctober 26, 2012
K110093SUPERDIMENSION MARKER DELIVERY KITFebruary 11, 2011
K102604I-LOGIC INREACH SYSTEMOctober 7, 2010
K092365INREACH SYSTEM, MODEL AAS00161-02September 4, 2009
K082386INREACH PLANNING LAPTOPSeptember 16, 2008
K081379MODIFICATION TO INREACH SYSTEMJune 11, 2008
K080271INREACH SYSTEMMarch 31, 2008
K071473MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2July 12, 2007
K062315SUPERDIMENSION/BRONCHUS PREMIUM 2September 8, 2006
K052852SUPERDIMENSION/BRONCHUS PREMIUMNovember 14, 2005
K052260SUPERDIMENSION/BRONCHUS 4.1September 8, 2005
K042438SUPERDIMENSION/BRONCHUSNovember 8, 2004