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FDA 510(k)

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight

K-Number: K170731 · 2017-04-04

ApplicantVATECH Co., Ltd.
Decision Date2017-04-04
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight is a medical device manufactured by VATECH Co., Ltd.. It received FDA 510(k) clearance on 2017-04-04 under approval number K170731. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight?

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight is a medical device that received FDA 510(k) clearance on 2017-04-04. It is manufactured by VATECH Co., Ltd.. The 510(k) number is K170731.

When was System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight approved by the FDA?

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight received FDA 510(k) clearance on 2017-04-04, under approval number K170731.

What company makes System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight?

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight is manufactured by VATECH Co., Ltd..

What is the FDA product code for System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight?

The FDA product code for System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight is MUH.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING NCT07601503 Evaluating In-line Chlorination in Nigeria NOT_YET_RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

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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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