FDA.reportPublic FDA data

OrthoGrid Hip AI

Primary DI
00860003424834
Brand
OrthoGrid Hip AI
Company
Orthogrid Systems, Inc.
Model
1015-915-505
Device description
OrthoGrid Hip AI for non-invasive software system that provides image analysis tools for Total Hip Replacement
Published
2022-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210136000PhantomMSK HipOrthoGrid Systems, Inc.2021-02-18LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003424834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003424834008600034248348600034248340860003424834

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fluoroscopic grid softwareA software program intended for use during an orthopaedic surgical procedure to enhance fluoroscopic images with a visual tool in the form of an overlaid grid, whereby the grid is intended to highlight fluoroscopic distortion and e.g., assist placement of an implant.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079674160
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003424841OrthoGrid Hip Trauma 2010-915-5072025-06-24
00860003424858Orthogrid Calibration Array 1020-915-1232025-06-24
00860003424865Orthogrid Calibration Array 1020-915-1242025-06-24
00860003424827OrthoGrid Hip Trauma 2010-915-5022021-08-27
00860003424803OrthoGrid Hip1015-915-5042021-03-05
00860003424810OrthoGrid Hip Preservation 4015-915-5012021-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850059977637TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
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00850059977675TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
75401622522125Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-08-07
00198953246405Xeleris V Processing and Review SystemG E MEDICAL SYSTEMS ISRAEL LTD.LLZ2026-08-03
00860011624349IntraOpVSPXironetic LLCLLZ2026-08-03
00862234000337Mosaic ViewerVirtual Radiologic CorporationLLZ2026-07-31
09358140000093Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-07-30
00866463000496STAGESpintech, Inc.LLZ2026-07-23
00854810007229iCRco Clarity ViewerIcRco, Inc.LLZ2026-07-22
17540262200102Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-07-22
17540262090161Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-07-21
M722CP26183V261830ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-07-17
00854393006084VelocityVARIAN MEDICAL SYSTEMS, INC.LLZ2026-07-16
G874AVARAVIEWER0010Avara ViewerAVARA SOFTWARE LLCLLZ2026-07-13
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08