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510(k) K193417

Device
FractureDetect (FX)
Applicant
Imagen Technologies, Inc.
510(k) number
K193417
Product code
QBS  
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-30
Date received
2019-12-09
Regulation
892.2090
Classification name
Radiological Computer Assisted Detection/diagnosis Software For Fracture
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Robert Lindsey
Address
Wework, 524 Broadway, 8th Floor New York NY US 10012 10012

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QBS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260378RayvolveAZmed2026-05-12
K242171TechCare TraumaMilvue2025-01-17
K240712icobrain ariaIcometrix NV2024-11-07
K240845RayvolveAzmed Sas2024-07-17
K223491Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care SuiteGe Medical Systems, LLC2023-05-25
K222176BoneViewGleamer2023-03-02
K220164RayvolveAzmed Sas2022-06-02
K212365BoneViewGleamer2022-03-01
DEN180005OsteoDetectImagen Technologies, Inc.2018-05-24

Legacy Summary#

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FDA Review#

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