FDA.reportPublic FDA data

3DIEMME RealGUIDE

Primary DI
08050038830003
Brand
3DIEMME RealGUIDE
Company
3DIEMME SRL
Model
RealGUIDE APP
Device description
Mobile version
Published
2019-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K173041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1730410003DIEMME RealGUIDE3Diemme , Ltd.2018-12-20LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08050038830003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050038830003080500388300038050038830003

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390317073353info@3diemme.it

Regulatory Flags#

DUNS number
857172105
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08050038833226RealGUIDE Z3D KIT, Empty Tray 3DM00632ZUS2026-03-10
08050038834407RealGUIDE Z3D Surgical Kit3DM0070ZUS2026-03-10
18050038834411RealGUIDE Sleeve3DM00605AZTC40.102026-03-10
18050038834428RealGUIDE Sleeve3DM00605AZTC50.102026-03-10
18050038834435RealGUIDE Sleeve3DM00605AZTC60.102026-03-10
18050038834442RealGUIDE Sleeve3DM00605NEOEG.102026-03-10
18050038834459RealGUIDE Sleeve3DM00605NEOGM.102026-03-10
18050038834466RealGUIDE Sleeve3DM00605NEOGMNRW.102026-03-10
18050038834473RealGUIDE Sleeve3DM00605NEOGMWD.102026-03-10
18050038834541RealGUIDE Sleeve3DM00605NEOEGNRW.102026-03-10
18050038834558RealGUIDE Sleeve3DM00605CAMPL33.102026-03-10
18050038834565RealGUIDE Sleeve3DM00605CAMPL38.102026-03-10
18050038834572RealGUIDE Sleeve3DM00605CAMPL43.102026-03-10
18050038834589RealGUIDE Sleeve3DM00605CAMPL50.102026-03-10
18050038834596RealGUIDE Sleeve3DM00605STRSL.102026-03-10
08050038832021RealGUIDE Surgical Kit3DM00700US2025-08-07
08050038832144RealGUIDE™ Z3D KIT, Empty Tray 3DM00632ZUS2024-12-06
08050038833165AZURE TAPERED BONE LEVEL GUIDED SURGICAL TRAY, EMPTY 3DM00632TBLTRAY2024-12-06
08050038831093RealGUIDE IMPLANT MOUNT3DM00606ZIM31US2022-07-01
08050038831109RealGUIDE IMPLANT MOUNT3DM00606ZIM35US2022-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00628184004500Intellijoint VIEWIntellijoint Surgical IncLLZ2026-06-09
00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05
08437021468212QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2026-06-05
B359OAIIV2026051RamsoftRamsoft IncLLZ2026-06-04
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13