3Di

Primary DI
07290018235003
Brand
3Di
Company
SHINA SYSTEMS LTD.
Model
3.2
Device description
3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET,SPECT, Ultrasound &Mammography) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls. 3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation,2D/3D image visualization, image processing, reporting and archiving. The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and CT colonoscopy.
Published
2020-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K113442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1134420003DIShina Systems , Ltd.2012-02-16LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018235003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018235003072900182350037290018235003

GMDN Terms#

Term, Definition table
TermDefinition
Radiology 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. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514770445
Device count
1

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