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FDA 510(k)

ClearVision ExamVue Flat Panel Detector

K-Number: K160143 · 2016-10-28

ApplicantJpi Healthcare, Inc.
Decision Date2016-10-28
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClearVision ExamVue Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Jpi Healthcare, Inc.. It received FDA 510(k) clearance on 2016-10-28 under 510(k) number K160143. 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 ClearVision ExamVue Flat Panel Detector?

ClearVision ExamVue Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2016-10-28. The listed applicant is Jpi Healthcare, Inc.. The 510(k) number is K160143.

When did ClearVision ExamVue Flat Panel Detector receive FDA 510(k) clearance?

ClearVision ExamVue Flat Panel Detector received FDA 510(k) clearance on 2016-10-28, under 510(k) number K160143.

Who is the listed applicant for ClearVision ExamVue Flat Panel Detector?

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

What is the FDA product code for ClearVision ExamVue Flat Panel Detector?

The FDA product code for ClearVision ExamVue Flat Panel Detector is MQB.

Related Clinical Trials

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.

NCT07092553Evaluation of C-arm PCD-CBCT for Image-Guided InterventionsNOT_YET_RECRUITING

Other records listing Jpi Healthcare, Inc. 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 DuoK244010ExamVue ApexK213057ExamVue Duo

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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