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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 the device name listed in this FDA 510(k) record. The listed applicant is Jpi Healthcare Co, Ltd.. It received FDA 510(k) clearance on 2025-02-24 under 510(k) 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. The listed applicant is Jpi Healthcare Co, Ltd.. The 510(k) number is K244010.

When did ExamVue Apex receive FDA 510(k) clearance?

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

Who is the listed applicant for ExamVue Apex?

The FDA 510(k) record lists Jpi Healthcare Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ExamVue Apex?

The FDA product code for ExamVue Apex is MQB.

Other records listing Jpi Healthcare Co, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260482DRE DuoK213057ExamVue DuoK160143ClearVision ExamVue Flat Panel Detector

Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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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