FDA.reportPublic FDA data

Neuroreader

Primary DI
05700002060433
Brand
Neuroreader
Company
Brainreader ApS
Model
2.3
Published
2017-09-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140828000NEUROREADER MEDICAL IMAGE PROCESSING SOFTWAREBrainreader Aps2015-02-04LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700002060419PreviousGS10
05700002060433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700002060419057000020604195700002060419
05700002060433057000020604335700002060433

GMDN Terms#

Term, Definition table
TermDefinition
Image segmentation application softwareAn application software program intended to convert large volumes of slice-based images into manageable three-dimensional (3-D) models of anatomical structures. It is typically used in an electrophysiology (EP) procedure (e.g., a cardiac mapping) to accept DICOM3 images from computed tomography (CT) and magnetic resonance imaging (MRI) scanners. Once the images are imported, a 3-D model can be extracted in a process called segmentation (the isolation of an object of interest) for easy viewing and manipulation during the EP procedure. This device is typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4553524749support@brainreader.net

Regulatory Flags#

DUNS number
305279427
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700002060471Neuroreader 2.72022-08-22
05700002060464Neuroreader 2.62021-06-28
05700002060457Neuroreader2.52020-12-14
05700002060419Neuroreader2.2.92017-05-04
05700002060440Neuroreader2.42018-09-11
05700002060402Neuroreader2.2.82016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.LLZ2026-10-19
05745000308385Cercare Medical NeurosuiteCercare Medical A/SLLZ2026-10-17
05745000308392Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-10-17
05745000308408Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-10-17
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SLLZ2026-10-16
75401622502301Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-16
00889024713390ROSA® ShoulderOrthosoft IncLLZ2026-10-15
B037FFSMD0Synapse MobilityResolutionMD Inc.LLZ2026-10-15
B037NLIVD0Nicolab Image ViewerResolutionMD Inc.LLZ2026-10-15
B037RESMDD0ResolutionMDResolutionMD Inc.LLZ2026-10-15
00860013868918MICSI-PETMicroStructure Imaging, Inc.LLZ2026-10-14
00745426000059MiPACS V5Medicor ImagingLLZ2026-10-12
75401622522132Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-08
00198953007716NAGE Medical Systems, L.L.C.LNH2026-10-07
00198953200421EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
05745000308323Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-01-30
05745000308330Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-01-30
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12