FDA.reportPublic FDA data

RealGUIDE

Primary DI
08050038833172
Brand
RealGUIDE
Company
3DIEMME SRL
Model
REALGUIDE WIN
Published
2026-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253902000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253902000RealGUIDE3DIEMME SRL2026-08-04QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08050038833172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050038833172080500388331728050038833172

Regulatory Flags#

DUNS number
441467351
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08050038833189RealGUIDEREALGUIDE MAC2026-08-31
08050038833196RealGUIDEREALGUIDE WEB2026-08-31
08050038833264RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS006212026-06-29
08050038833271RealGUIDE Surgical InstrumentsSTRMTAGL-63DMUS006102026-06-30
08050038833288RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.16.0702026-06-29
08050038833295RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.16.1152026-06-29
08050038833301RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.16.1502026-06-29
08050038833318RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.21.1502026-06-29
08050038833325RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.23.0852026-06-29
08050038833332RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.23.1002026-06-29
08050038833349RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.23.1152026-06-29
08050038833356RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.23.1302026-06-29
08050038833394RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.23.1602026-06-29
08050038833400RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.24.080Z2026-06-29
08050038833417RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.24.100Z2026-06-29
08050038833424RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.24.115Z2026-06-29
08050038833431RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.24.130Z2026-06-29
08050038833448RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.24.1502026-06-29
08050038833455RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.24.160Z2026-06-29
08050038833462RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.28.080Z2026-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547410575392Synapse 3DFUJIFILM CORPORATIONLLZ2026-10-30
04547410575392Synapse 3DFUJIFILM CORPORATIONQIH2026-10-30
05404028001370Mimics Cardiac PlannerMaterialise NVLLZ2026-10-30
B745ELUCIDB1P1Elucid Plaque-IQELUCID BIOIMAGING INC.LLZ2026-10-29
04719878712002OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.LLZ2026-10-28
00889024671270ROSA® HipOrthosoft IncLLZ2026-10-27
00860013056506Cirrus Software ApplicationSORA NEUROSCIENCE, INC.QIH2026-10-26
00889024705999NavitrackerOrthosoft IncLLZ2026-10-26
00850018318020Bladder AIExo Imaging, Inc.QIH2026-10-22
00850018318075AI Platform IIExo Imaging, Inc.QIH2026-10-22
00850018318082Strain AIExo Imaging, Inc.QIH2026-10-22
03770033463055FETOLYDIAGNOLYQIH2026-10-22
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22