FDA.reportPublic FDA data

Grin App

Primary DI
D962GGA00001
Brand
Grin App
Company
Get-Grin Inc.
Model
Initial Release
Published
2020-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D962GGA00001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117178760
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D962GGSLG004Grin Scope LGLimited editionGGSLG0042025-09-16
D962GGSLG005Grin Scope LGmass production versionGGSLG0052025-09-16
D962GGSMLG04Grin Scope Mini LGLimited editionGGSMLG042025-09-16
D962GGSMLG05Grin Scope Mini LGmass production versionGGSMLG052025-09-16
D962GGAR0003Grin Records AppInitial Release2023-11-20
D962GGAW0002Grin App -WW Version2022-04-26
D962GGW00001Grin WebsiteInitial Release2020-08-12
D962GGS00003Grin Scope Version 2Version 22022-04-26
D962GGSW0003Grin Scope Version 2 -WVersion 2 -W2022-04-26
D962GGSM0001Get Grin Scope MiniIM Version2021-04-27
D962GGS00001Grin ScopeIM Version2020-08-12
D962GGS00002Grin Scope3D Print Version2020-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025268424Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-05-12
08800026700890Medit AuraVueMedit Corp.LMD2026-05-11
00810111225663X-ray AppTreace Medical Concepts, Inc.LMD2026-05-01
00628105001212Vitrea ReadCanon Medical Informatics A/SLMD2026-04-27
05415334057258Eonis 32”Barco NVLMD2026-04-13
00628105001229Vitrea ReadCanon Medical Informatics A/SLMD2026-04-03
EPIS960010EpisurfViewEpisurf Operations ABLMD2026-03-17
07290018052402aiOSAIDOC MEDICAL LTDLMD2026-03-08
00850025268400Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-02-27
04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
00850025268394Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-01-21
05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
00850054590152interWORKSAvreo IncLMD2025-12-08
05415334053045Eonis 3DBarco NVLMD2025-12-01
00628105001205Vitrea ReadCanon Medical Informatics A/SLMD2025-11-21
00850013331086SentiARSentiar, Inc.LMD2025-11-21
00850013331093SentiARSentiar, Inc.LMD2025-11-21
00850013331109SentiARSentiar, Inc.LMD2025-11-21
00850061871374IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.LMD2025-11-18
00850054590145interWORKSAvreo IncLMD2025-11-14
00850025268387Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-11-03
00850025268370Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-09-24
00857534006868IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
00857534006875IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
03770024341072Sonio Pro v3SONIOLMD2025-08-28
00850054590138interWORKSAvreo IncLMD2025-08-26
00628105001199Vitrea ReadCanon Medical Informatics A/SLMD2025-08-15
00818834028837MiiS Horus Endoscope Display System -Video BoxTRI-ANIM HEALTH SERVICES, INC.LMD2025-08-12
08800184000009I-Rapha ViewIRM IncLMD2025-08-01