510(k) K042605

Device: COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
Applicant: SIEMENS AG, MEDICAL SOLUTIONS
510(k) number: K042605
Product code: NWE
Decision: Substantially Equivalent (SESE)
Decision date: 2004-10-08
Date received: 2004-09-24
Regulation: 892.2050
Classification name: Colon Computed Tomography System, Computer Aided Detection
Medical specialty: Radiology
Review panel: Radiology
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: Yes

Applicant Contact#

Contact: RUDIGER KORNER
Address: Henkestrasse 127 Erlangen DE 91052 91052

FDA Registration Numbers#

3004977335

Source Documents#

Other 510(k) Records For Product Code NWE #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K140920	SYNGO.CT COLONOGRAPHY	Siemens Medical Solutions USA, Inc.	2014-12-03
K083423	COLONCAD API 3.1	Medicsight Plc	2011-05-17
K042674	COLON CAR 1.2	Medicsight	2004-10-19

Legacy Summary#

summary

FDA Review#

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