PENTAX Medical EPK-3000 Video Imaging System
K-Number: K182846 · 2019-01-09
ApplicantPentax of America, Inc.
Decision Date2019-01-09
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
PENTAX Medical EPK-3000 Video Imaging System is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-01-09 under approval number K182846. 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 2019-01-09. It is manufactured by Pentax of America, Inc.. The 510(k) number is K182846.
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 2019-01-09, under approval number K182846.
What company makes PENTAX Medical EPK-3000 Video Imaging System?
PENTAX Medical EPK-3000 Video Imaging System is manufactured by Pentax of America, Inc..
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.
Related Clinical Trials
NCT01143558
Searching for Persistence of Infection in Lyme Disease
COMPLETED
NCT01143454
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
RECRUITING
NCT07137455
EDEN Intracardiac Electrogram Recording and Classifying System
ENROLLING_BY_INVITATION
NCT01174108
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
RECRUITING
NCT03280862
DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS
COMPLETED
NCT03331380
Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
RECRUITING
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: 42175114
Make Open Source Compliant: Validation in Non-Interventional Clinical Studies.
Studies in health technology and informatics (2026)
PMID: 42174947
Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks.
Studies in health technology and informatics (2026)
PMID: 42056377
Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh.
Scientific reports (2026)
Other Devices by Pentax of America, Inc.
K162151PENTAX Medical ENT Video Imaging System
K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner
K182004PENTAX Medical Endoscopic Ultrasound System
K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope
K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope
Related Devices (Code: EOB)
K153701ULYSS Multi View SinuscopeSopro-Comeg GmbH
K153009ULTRA TelescopesOlympus Winter & Ibe GmbH
K152531InstaClear Lens CleanerGyrus Acmi, Inc.
K170453Medrobotics Flex Robotic SystemMedrobotics Corporation
K161298ShenDa SinuscopeShenyang Shenda Endoscope Co., Ltd.
K170285AED SinuscopeNational Advanced Endoscopy Devices, 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.