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FDA 510(k)

COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY

K-Number: K042605 · 2004-10-08

ApplicantSiemens AG Medical Solutions
Decision Date2004-10-08
Product CodeNWE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY is the device name listed in this FDA 510(k) record. The listed applicant is Siemens AG Medical Solutions. It received FDA 510(k) clearance on 2004-10-08 under 510(k) number K042605. The device is classified under product code NWE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY?

COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY is a medical device that received FDA 510(k) clearance on 2004-10-08. The listed applicant is Siemens AG Medical Solutions. The 510(k) number is K042605.

When did COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY receive FDA 510(k) clearance?

COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY received FDA 510(k) clearance on 2004-10-08, under 510(k) number K042605.

Who is the listed applicant for COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY?

The FDA 510(k) record lists Siemens AG Medical Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY?

The FDA product code for COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY is NWE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Siemens AG Medical Solutions as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123920SYNGO.VIAK120331SYNGO CT DYNAMIC ANGIOK111079SYNGO.VIA WEB VIEWERK101666SYNGO. PLAZA VA20AK100637SYNGO.CT CORONARY ANALYSISK093612SYNGO.PLAZA

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Related Devices (Code: NWE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K083423COLONCAD API 3.1Medicsight PlcK042674COLON CAR 1.2Medicsight

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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