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FDA 510(k)

ENDOSCOPY VIDEO CAMERA SYSTEM

K-Number: K081585 · 2008-06-20

ApplicantVision Systems Group, A Division of Viking Systems
Decision Date2008-06-20
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPY VIDEO CAMERA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vision Systems Group, A Division of Viking Systems. It received FDA 510(k) clearance on 2008-06-20 under 510(k) number K081585. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPY VIDEO CAMERA SYSTEM?

ENDOSCOPY VIDEO CAMERA SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-20. The listed applicant is Vision Systems Group, A Division of Viking Systems. The 510(k) number is K081585.

When did ENDOSCOPY VIDEO CAMERA SYSTEM receive FDA 510(k) clearance?

ENDOSCOPY VIDEO CAMERA SYSTEM received FDA 510(k) clearance on 2008-06-20, under 510(k) number K081585.

Who is the listed applicant for ENDOSCOPY VIDEO CAMERA SYSTEM?

The FDA 510(k) record lists Vision Systems Group, A Division of Viking Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOSCOPY VIDEO CAMERA SYSTEM?

The FDA product code for ENDOSCOPY VIDEO CAMERA SYSTEM is FET.

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 Vision Systems Group, A Division of Viking Systems 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.

K1018103DHJD CAMERA SYSTEM MODEL

Related Devices (Code: FET)

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.

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.

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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