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)

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 a medical device manufactured by Careray Digital Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-30 under approval 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. It is manufactured by Careray Digital Medical Technology Co., Ltd.. The 510(k) number is K223687.

When was X-ray Flat Panel Detectors (EverestView 4343X) approved by the FDA?

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

What company makes X-ray Flat Panel Detectors (EverestView 4343X)?

X-ray Flat Panel Detectors (EverestView 4343X) is manufactured by Careray Digital Medical Technology Co., Ltd..

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.

Other Devices by Careray Digital Medical Technology Co., Ltd.

K221549X-ray Flat Panel Detectors (CareView 1800 RF) K232058YosemiteView 4343W/YosemiteView 3643W

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.

↑