FDA.reportPublic FDA data

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert

Primary DI
05745000308125
Brand
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert
Company
Cercare Medical A/S
Model
14
Device description
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 14
Published
2024-05-21
Public version status
Update
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202793000Cercare Medical NeurosuiteCercare Medical Aps2021-05-17LLZ
K230016000Cercare Medical NeurosuiteCercare Medical A/S2023-07-14LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05745000308071PreviousGS10
05745000308125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05745000308071057450003080715745000308071
05745000308125057450003081255745000308125

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
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
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
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

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00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03
00817886020493JointsMEDSTRAT, INC.LLZ2023-03-06
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05
00817886020455JointsMEDSTRAT, INC.LLZ2022-08-01