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FDA 510(k)

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes

K-Number: K183640 · 2019-02-22

ApplicantMauna Kea Technologies
Decision Date2019-02-22
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes is a medical device manufactured by Mauna Kea Technologies. It received FDA 510(k) clearance on 2019-02-22 under approval number K183640. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes?

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes is a medical device that received FDA 510(k) clearance on 2019-02-22. It is manufactured by Mauna Kea Technologies. The 510(k) number is K183640.

When was Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes approved by the FDA?

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes received FDA 510(k) clearance on 2019-02-22, under approval number K183640.

What company makes Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes?

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes is manufactured by Mauna Kea Technologies.

What is the FDA product code for Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes?

The FDA product code for Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes is OWN.

Related Clinical Trials

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Related PubMed Literature

PMID: 42207283 [Legal responsibility in AI-assisted radiological reporting]. Radiologie (Heidelberg, Germany) (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41929241 A Multidimensional Index Framework for Evaluating the Regulatory Applicability of ISO 10328 Using a Prosthetic Knee Case Study. Medical devices (Auckland, N.Z.) (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026)

Other Devices by Mauna Kea Technologies

K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes K172844Cellvizio 100 Series System with Confocal Miniprobes K171345Cellvizio 100 Series Systems with Confocal Miniprobes K180270Cellvizio 100 Series Systems with Confocal Miniprobes K193416Cellvizio I.V.E. with Confocal Miniprobes K191144Cellvizio 100 Series System with Confocal Miniprobes

View all 9 devices →

Related Devices (Code: OWN)

K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies K171345Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.

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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