FDA.reportPublic FDA data

MYRIAN

Primary DI
03700719700471
Brand
MYRIAN
Company
INTRASENSE
Model
MYRIAN 2.9
Device description
Myrian® is a medical software for processing, management, advanced visualization, and analysis of multimodality medical images. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including radiologists, surgeons, clinicians and technicians. This device is not indicated for mammography use.
Published
2021-02-24
Public version status
New
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
K113620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113620000MYRIAN 1.11Intrasense2012-07-12LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700719700471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700719700471037007197004713700719700471

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
272423299
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
03700719700419MYRIANMYRIAN 2.42018-07-09
03700719700426MYRIANMYRIAN 2.52018-12-05
03700719700433MYRIANMYRIAN 2.62018-12-19
03700719700464MYRIANMYRIAN 2.7.62020-04-21
03700719700013MYRIANMYRIAN 2.12016-11-04
03700719700396MYRIANMYRIAN 2.22017-04-07
03700719700402MYRIANMYRIAN 2.32017-10-25
03700719700457MYRIANMYRIAN 2.82020-08-17
03700719700440MYRIANMYRIAN 2.72019-10-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800018412008EConsole2DRTECH CorporationLLZ2026-03-17
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09358140000079Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-03-09
17540262090154Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-03-09
06971576834334uWSShanghai United Imaging Healthcare Co., Ltd.LLZ2026-03-08
06971576834341uWSShanghai United Imaging Healthcare Co., Ltd.LLZ2026-03-08
07350092810678Sectra Orthopedic PackageSectra ABLLZ2026-03-05
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00850025268400Vitrea Advanced Visualization Canon Medical Informatics, Inc.LLZ2026-02-27
08800169200134ON3D3D ONS, INC.LLZ2026-02-19
B403IQS11004iQ-SYSTEM PACSIMAGE Information Systems Europe GmbHLLZ2026-02-19
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00860015443526CARPLCarpl.AI, Inc.LLZ2026-02-16