0909FCC, 0909FCC-HS
K-Number: K240371 · 2024-03-07
ApplicantRayence Co., Ltd.
Decision Date2024-03-07
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
0909FCC, 0909FCC-HS is a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2024-03-07 under approval number K240371. 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 0909FCC, 0909FCC-HS?
0909FCC, 0909FCC-HS is a medical device that received FDA 510(k) clearance on 2024-03-07. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K240371.
When was 0909FCC, 0909FCC-HS approved by the FDA?
0909FCC, 0909FCC-HS received FDA 510(k) clearance on 2024-03-07, under approval number K240371.
What company makes 0909FCC, 0909FCC-HS?
0909FCC, 0909FCC-HS is manufactured by Rayence Co., Ltd..
What is the FDA product code for 0909FCC, 0909FCC-HS?
The FDA product code for 0909FCC, 0909FCC-HS is MQB.
Other Devices by Rayence Co., Ltd.
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.