510(k) K042674

Device: COLON CAR 1.2
Applicant: MEDICSIGHT
510(k) number: K042674
Product code: NWE
Decision: Substantially Equivalent (SESE)
Decision date: 2004-10-19
Date received: 2004-09-29
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: No

Applicant Contact#

Contact: CAROL MACDONALD
Address: 46 Berkeley Sq. London GB W1J 5AT W1J 5AT

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
K042605	COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY	Siemens AG Medical Solutions	2004-10-08

Legacy Summary#

summary

FDA Review#

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