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510(k) K192629

Device
Spinalytics
Applicant
Optima Health Solutions International Corp.
510(k) number
K192629
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2019-12-21
Date received
2019-09-23
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Neurology
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Farhad Ghani
Address
Unit 303 - 828 W 8th Ave. Vancouver CA V5Z 1E2 V5Z 1E2

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
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
K2538993D-AnywhereProvect.AI2026-07-09
K261465INDIRA CLOUD VIEWERINDIGO TECHNOLOGIES2026-07-06
K260576MeVis AVM ContourMeVis Medical Solutions AG2026-06-30
K260231MiPACS V5 (1.0.0)Apryse Software Corp2026-06-25
K253421Perfusion Measurement Platform v1Quantified Imaging Limited2026-06-22
K2613522D Hip Planning SoftwareOne Ortho2026-06-08

Legacy Summary#

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FDA Review#

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