510(k) K083423

Device: COLONCAD API 3.1
Applicant: MEDICSIGHT PLC
510(k) number: K083423
Product code: NWE
Decision: Substantially Equivalent (SESE)
Decision date: 2011-05-17
Date received: 2008-11-19
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: AMARJIT GILL
Address: 66 Hammersmith Rd. London GB W148UD W148UD

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
K042674	COLON CAR 1.2	Medicsight	2004-10-19
K042605	COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY	Siemens AG Medical Solutions	2004-10-08

Legacy Summary#

summary

FDA Review#

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