FDA 510(k)

DR-ID 1200SDK System

K-Number: K200668 · 2020-04-10

Decision Date2020-04-10

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DR-ID 1200SDK System is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2020-04-10 under approval number K200668. 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 DR-ID 1200SDK System?

DR-ID 1200SDK System is a medical device that received FDA 510(k) clearance on 2020-04-10. It is manufactured by Fujifilm Corporation. The 510(k) number is K200668.

When was DR-ID 1200SDK System approved by the FDA?

DR-ID 1200SDK System received FDA 510(k) clearance on 2020-04-10, under approval number K200668.

What company makes DR-ID 1200SDK System?

DR-ID 1200SDK System is manufactured by Fujifilm Corporation.

What is the FDA product code for DR-ID 1200SDK System?

The FDA product code for DR-ID 1200SDK System is MQB.

Other Devices by Fujifilm Corporation

K182051FUJIFILM Duodenoscope Model K181773Synapse 3D Optional Tools K180341FUJIFILM 600 Series Endoscope EG-600WR v2 K181763FUJIFILM Ultrasonic Endoscope K180711FUJIFILM Endoscopic CO2 Regulator GW-100 K180405FUJIFILM Endoscope Models EC-600HL and EC-600LS

View all 62 devices →

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.