Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ExamVue Apex

K-Number: K244010 · 2025-02-24

ApplicantJpi Healthcare Co, Ltd.
Decision Date2025-02-24
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ExamVue Apex is a medical device manufactured by Jpi Healthcare Co, Ltd.. It received FDA 510(k) clearance on 2025-02-24 under approval number K244010. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ExamVue Apex?

ExamVue Apex is a medical device that received FDA 510(k) clearance on 2025-02-24. It is manufactured by Jpi Healthcare Co, Ltd.. The 510(k) number is K244010.

When was ExamVue Apex approved by the FDA?

ExamVue Apex received FDA 510(k) clearance on 2025-02-24, under approval number K244010.

What company makes ExamVue Apex?

ExamVue Apex is manufactured by Jpi Healthcare Co, Ltd..

What is the FDA product code for ExamVue Apex?

The FDA product code for ExamVue Apex is MQB.

Other Devices by Jpi Healthcare Co, Ltd.

K213057ExamVue Duo

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, 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.

↑