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
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
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
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
00817886020448JointsMEDSTRAT, INC.LLZ2022-06-17
00817886020431JointsMEDSTRAT, INC.LLZ2022-04-29
00817886020424JointsMEDSTRAT, INC.LLZ2022-04-01
00817886020417JointsMEDSTRAT, INC.LLZ2022-02-19
00817886020400JointsMEDSTRAT, INC.LLZ2021-12-16
00817886020394JointsMEDSTRAT, INC.LLZ2021-10-15
00817886020387JointsMEDSTRAT, INC.LLZ2021-09-08
00817886020370JointsMEDSTRAT, INC.LLZ2021-07-30
00817886020363JointsMEDSTRAT, INC.LLZ2021-07-02
00817886020356JointsMEDSTRAT, INC.LLZ2021-06-01
00817886020349JointsMEDSTRAT, INC.LLZ2021-04-05
00817886020332JointsMEDSTRAT, INC.LLZ2021-02-26
00817886020325JointsMEDSTRAT, INC.LLZ2021-01-29