AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
K-Number: K231709 · 2023-07-12
ApplicantRadmedix, LLC
Decision Date2023-07-12
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 is a medical device manufactured by Radmedix, LLC. It received FDA 510(k) clearance on 2023-07-12 under approval number K231709. 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 AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4?
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 is a medical device that received FDA 510(k) clearance on 2023-07-12. It is manufactured by Radmedix, LLC. The 510(k) number is K231709.
When was AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 approved by the FDA?
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 received FDA 510(k) clearance on 2023-07-12, under approval number K231709.
What company makes AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4?
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 is manufactured by Radmedix, LLC.
What is the FDA product code for AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4?
The FDA product code for AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 is MQB.
Other Devices by Radmedix, LLC
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.