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510(k) K112109

Device
THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE
Applicant
ORTHO KINEMATICS, INC.
510(k) number
K112109
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2011-12-22
Date received
2011-07-22
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN J SMITH
Address
555 13th St., NW Washington DC US 20005 20005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LLZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261874Syneris PACS v.1.0.1.0Syneris2026-09-23
K262442HipStudio AnalysisReplasia BV2026-09-22
K261855Elucid PlaqueIQElucid Bioimaging, Inc.2026-09-18
K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.2026-09-15
K261861SPINEsim v1.0Mdsim S.A.2026-09-15
K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC2026-09-04
K261500KBA3D (v2.4.0)S.M.A.I.O2026-08-17
K262449AdvaViewADVAHEALTH SOLUTIONS, LLC2026-08-14
K261916NeuroQuant PETCortechs Labs, Inc.2026-08-12
K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)2026-07-31
K260588Cleerly LABSCleerly, Inc.2026-07-29
K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation2026-07-24
K262143ImageGrid StreamVueCandelis, Inc.2026-07-23
K260500ResolutionMDResolutionMD, Inc.2026-07-21
K262120Avara ViewerAvara Software2026-07-10

Legacy Summary#

summary

FDA Review#

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