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510(k) K140920

Device
SYNGO.CT COLONOGRAPHY
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
510(k) number
K140920
Product code
NWE  
Decision
Substantially Equivalent (SESE)
Decision date
2014-12-03
Date received
2014-04-10
Regulation
892.2050
Classification name
Colon Computed Tomography System, Computer Aided Detection
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KIMBERLY MANGUM
Address
51 Valley Stream Pkwy. Mavern PA US 19355 19355

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NWE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K083423COLONCAD API 3.1Medicsight Plc2011-05-17
K042674COLON CAR 1.2Medicsight2004-10-19
K042605COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITYSiemens AG Medical Solutions2004-10-08

Legacy Summary#

summary

FDA Review#

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