FDA.reportPublic FDA data

Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual Ex

Primary DI
05745000308361
Brand
Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual Ex
Company
Cercare Medical A/S
Model
18
Device description
Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual Expert ver. 18
Published
2026-10-16
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
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
K202793000
K230016000
K241989000
K260316000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202793000Cercare Medical NeurosuiteCercare Medical Aps2021-05-17LLZ
K230016000Cercare Medical NeurosuiteCercare Medical A/S2023-07-14LLZ
K241989000Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/S2024-12-06LLZ
K260316000CMN Capillary Function with Oncology Virtual ExpertCercare Medical A/S2026-06-22QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05745000308361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05745000308361057450003083615745000308361

GMDN Terms#

Term, Definition table
TermDefinition
Brain CT/MRI clinical assessment support softwareA software program intended to display, analyse/process, and possibly acquire computed tomography (CT) and/or magnetic resonance imaging (MRI) data of the brain (includes intracranial vessels), to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of a brain condition (e.g., occlusion, aneurysm, haemorrhage, stroke, neurodegenerative disease). It is not dedicated to treatment planning or surgical navigation, and 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
05745000308385Cercare Medical Neurosuite192026-10-17
05745000308392Cercare Medical Neurosuite with Capillary Function192026-10-17
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
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
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
19356870000069PHA4DMEDICAL LIMITEDQIH2026-10-13
00745426000059MiPACS V5Medicor ImagingLLZ2026-10-12
00198953083246VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
75401622522132Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-08
00198953200421EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200421EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
04262352357645DS Core DiagnosisZetta25 AGQIH2026-10-06
00860006442651cmAngioCuremetrix, Inc.QIH2026-10-05
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
08809887550170EdgeFlow UH10CEdgeCare Inc.QIH2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.QIH2026-09-30
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
00195278985613NAGE Medical Systems (China) Co.,Ltd.QIH2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SQIH2026-09-21