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)

Flat Panel Detector

K-Number: K201591 · 2020-09-03

ApplicantKa Imaging, Inc.
Decision Date2020-09-03
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Flat Panel Detector is a medical device manufactured by Ka Imaging, Inc.. It received FDA 510(k) clearance on 2020-09-03 under approval number K201591. 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 Flat Panel Detector?

Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2020-09-03. It is manufactured by Ka Imaging, Inc.. The 510(k) number is K201591.

When was Flat Panel Detector approved by the FDA?

Flat Panel Detector received FDA 510(k) clearance on 2020-09-03, under approval number K201591.

What company makes Flat Panel Detector?

Flat Panel Detector is manufactured by Ka Imaging, Inc..

What is the FDA product code for Flat Panel Detector?

The FDA product code for Flat Panel Detector is MQB.

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.

↑