FDA.reportPublic FDA data

NeuViz Prime Multi-Slice CT Scanner System

Primary DI
06970167440077
Brand
NeuViz Prime Multi-Slice CT Scanner System
Company
Neusoft Medical Systems Co., Ltd.
Model
NeuViz Prime
Published
2018-03-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171201000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171201000NeuViz Prime Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.2017-09-13JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970167440077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970167440077069701674400776970167440077

GMDN Terms#

Term, Definition table
TermDefinition
Full-body CT systemAn assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
724421537
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970167440008NeuViz 64 Multi-slice CT Scanner SystemNeuViz 64i2016-09-19
06970167440015NeuViz 64 Multi-slice CT Scanner SystemNeuViz 64e2016-09-19
06970167440039NeuViz 64 Multi-slice CT Scanner SystemNeuViz 64 En2016-09-19
06970167440022NeuViz 64 Multi-slice CT Scanner SystemNeuViz 64 In2016-09-19
06970167441616NeuViz 128 Multi-Slice CT Scanner SystemNeuViz 1282023-10-23
06970167440046NeuViz 128 Multi-slice CT Scanner SystemNeuViz 128 2016-09-19
06970167440053NeuSight PET/CT Scanner SystemNeuSight PET/CT 642016-09-19
06970167440060NeuSight PET/CT Scanner SystemNeuSight PET/CT 162016-09-19
06970167440084NeuViz 16 Essence Multi-Slice CT Scanner SystemNeuViz 16 Essence2018-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
00860015781925Bunkerhill Contrast AVCBunkerhill Health Inc.JAK2026-09-16
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00860015781901CAC (Gated) AlgorithmBunkerhill Health Inc.JAK2026-05-13
00198953085950PhotonovaGE Medical Systems, L.L.C.JAK2026-05-11
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00195278940292RevolutionGE Hangwei Medical Systems Company Ltd.JAK2025-02-28
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00860003424834OrthoGrid Hip AIOrthogrid Systems, Inc.LLZ2022-05-19
07649990819006OsiriX MDPixmeo SàrlLLZ2022-02-19
00860003424827OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2021-08-27
00860003424803OrthoGrid HipOrthogrid Systems, Inc.LLZ2021-03-05
00860003424810OrthoGrid Hip PreservationOrthogrid Systems, Inc.LLZ2021-03-05
00817886020332JointsMEDSTRAT, INC.LLZ2021-02-26
00817886020325JointsMEDSTRAT, INC.LLZ2021-01-29