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FDA 510(k)

COLONCAD API 3.1

K-Number: K083423 · 2011-05-17

ApplicantMedicsight Plc
Decision Date2011-05-17
Product CodeNWE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COLONCAD API 3.1 is the device name listed in this FDA 510(k) record. The listed applicant is Medicsight Plc. It received FDA 510(k) clearance on 2011-05-17 under 510(k) number K083423. 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 COLONCAD API 3.1?

COLONCAD API 3.1 is a medical device that received FDA 510(k) clearance on 2011-05-17. The listed applicant is Medicsight Plc. The 510(k) number is K083423.

When did COLONCAD API 3.1 receive FDA 510(k) clearance?

COLONCAD API 3.1 received FDA 510(k) clearance on 2011-05-17, under 510(k) number K083423.

Who is the listed applicant for COLONCAD API 3.1?

The FDA 510(k) record lists Medicsight Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLONCAD API 3.1?

The FDA product code for COLONCAD API 3.1 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

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.

K042674COLON CAR 1.2MedicsightK042605COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITYSiemens AG Medical Solutions

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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