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FDA 510(k)

X-ray Flat Panel Detectors (EverestView 4343X)

K-Number: K223687 · 2022-12-30

ApplicantCareray Digital Medical Technology Co., Ltd.
Decision Date2022-12-30
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-ray Flat Panel Detectors (EverestView 4343X) is the device name listed in this FDA 510(k) record. The listed applicant is Careray Digital Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-30 under 510(k) number K223687. 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 X-ray Flat Panel Detectors (EverestView 4343X)?

X-ray Flat Panel Detectors (EverestView 4343X) is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Careray Digital Medical Technology Co., Ltd.. The 510(k) number is K223687.

When did X-ray Flat Panel Detectors (EverestView 4343X) receive FDA 510(k) clearance?

X-ray Flat Panel Detectors (EverestView 4343X) received FDA 510(k) clearance on 2022-12-30, under 510(k) number K223687.

Who is the listed applicant for X-ray Flat Panel Detectors (EverestView 4343X)?

The FDA 510(k) record lists Careray Digital Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-ray Flat Panel Detectors (EverestView 4343X)?

The FDA product code for X-ray Flat Panel Detectors (EverestView 4343X) 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 Careray Digital Medical Technology 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.

K232058YosemiteView 4343W/YosemiteView 3643WK221549X-ray Flat Panel Detectors (CareView 1800 RF)

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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