FDA.reportPublic FDA data

Cercare Medical Neurosuite with Capillary Function

Primary DI
05745000308392
Brand
Cercare Medical Neurosuite with Capillary Function
Company
Cercare Medical A/S
Model
19
Device description
Cercare Medical Neurosuite with Capillary Function ver. 19
Published
2026-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K202793000
K230016000
K253831000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202793000Cercare Medical NeurosuiteCercare Medical Aps2021-05-17LLZ
K230016000Cercare Medical NeurosuiteCercare Medical A/S2023-07-14LLZ
K253831000CMN Capillary Function with Virtual Expert for MRI, CT and CBCTCercare Medical A/S2026-05-18LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05745000308392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05745000308392057450003083925745000308392

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
305457217
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual Ex182026-10-16
05745000308385Cercare Medical Neurosuite192026-10-17
05745000308408Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert192026-10-17
05745000308323Cercare Medical Neurosuite with Capillary Function182026-01-30
05745000308330Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert182026-01-30
05745000308316Cercare Medical Neurosuite182026-01-30
05745000308255Cercare Medical Neurosuite172025-06-07
05745000308262Cercare Medical Neurosuite with Capillary Function172025-06-07
05745000308279Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert172025-06-07
05745000308200Cercare Medical Neurosuite162024-12-06
05745000308217Cercare Medical Neurosuite with Capillary Function162024-12-06
05745000308224Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert162024-12-06
05745000308156Cercare Medical Neurosuite152024-06-06
05745000308163Cercare Medical Neurosuite with Capillary Function152024-06-06
05745000308170Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert152024-06-06
05745000308101Cercare Medical Neurosuite142024-05-21
05745000308118Cercare Medical Neurosuite with Capillary Function142024-05-21
05745000308125Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert142024-05-21
05745000308057Cercare Medical Neurosuite2023-06-012023-11-09
05745000308064Cercare Medical Neurosuite with Capillary Function2023-06-012023-11-09

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
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
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
00195278951700EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
00195278951717EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
03663999000375spineEOSEOS IMAGINGLLZ2025-08-01