FDA.reportPublic FDA data

Cercare Medical Neurosuite

Primary DI
05745000308156
Brand
Cercare Medical Neurosuite
Company
Cercare Medical A/S
Model
15
Device description
Cercare Medical Neurosuite ver. 15
Published
2024-06-06
Public version status
New
Distribution status
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
05745000308156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05745000308156057450003081565745000308156

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
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
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
00866463000496STAGESpintech, Inc.LLZ2026-07-23
00854810007229iCRco Clarity ViewerIcRco, Inc.LLZ2026-07-22
17540262200102Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-07-22
17540262090161Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-07-21
M722CP26183V261830ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-07-17
00854393006084VelocityVARIAN MEDICAL SYSTEMS, INC.LLZ2026-07-16
G874AVARAVIEWER0010Avara ViewerAVARA SOFTWARE LLCLLZ2026-07-13
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26