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FDA 510(k)

PENTAX Medical EPK-3000 Video Imaging System

K-Number: K172156 · 2018-04-05

ApplicantPentax Medical
Decision Date2018-04-05
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical EPK-3000 Video Imaging System is a medical device manufactured by Pentax Medical. It received FDA 510(k) clearance on 2018-04-05 under approval number K172156. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX Medical EPK-3000 Video Imaging System?

PENTAX Medical EPK-3000 Video Imaging System is a medical device that received FDA 510(k) clearance on 2018-04-05. It is manufactured by Pentax Medical. The 510(k) number is K172156.

When was PENTAX Medical EPK-3000 Video Imaging System approved by the FDA?

PENTAX Medical EPK-3000 Video Imaging System received FDA 510(k) clearance on 2018-04-05, under approval number K172156.

What company makes PENTAX Medical EPK-3000 Video Imaging System?

PENTAX Medical EPK-3000 Video Imaging System is manufactured by Pentax Medical.

What is the FDA product code for PENTAX Medical EPK-3000 Video Imaging System?

The FDA product code for PENTAX Medical EPK-3000 Video Imaging System is EOB.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42127793 Ethical Responsibility in the Off-Label Use of AI in Medical Imaging. The Journal of clinical ethics (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Pentax Medical

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Related Devices (Code: EOB)

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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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