FDA.reportPublic FDA data

Cercare Medical Neurosuite

Primary DI
05745000308057
Brand
Cercare Medical Neurosuite
Company
Cercare Medical A/S
Model
2023-06-01
Published
2023-11-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202793000Cercare Medical NeurosuiteCercare Medical Aps2021-05-17LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05745000308057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05745000308057057450003080575745000308057

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305457217
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05745000308316Cercare Medical Neurosuite182026-01-30
05745000308323Cercare Medical Neurosuite with Capillary Function182026-01-30
05745000308330Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert182026-01-30
05745000308255Cercare Medical Neurosuite172025-06-07
05745000308262Cercare Medical Neurosuite with Capillary Function172025-06-07
05745000308279Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert172025-06-07
05745000308224Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert162024-12-06
05745000308200Cercare Medical Neurosuite162024-12-06
05745000308217Cercare Medical Neurosuite with Capillary Function162024-12-06
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
05745000308064Cercare Medical Neurosuite with Capillary Function2023-06-012023-11-09
05745000308071Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert2023-06-012023-11-09
05745000308002Cercare Medical NeurosuiteCercare Medical Neurosuite2023-05-04
05745000308019Cercare Medical Neurosuite with Capillary FunctionCMN with Capillary Function (MR)2023-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25