Avara Viewer

Primary DI
G874AVARAVIEWER0010
Brand
Avara Viewer
Company
AVARA SOFTWARE LLC
Model
1.0.0
Device description
Avara Viewer is a software-only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM data, including mammographic images. It is designed to support the physician in diagnosis. Typical users of this system are trained medical professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Avara Viewer operates as a high-performance, web-compatible package for PACS servers designed to aid professionals in everyday clinical decision-making, connecting radiological medical data into a unified and fast-performing network. The system ensures a fast, reliable, and secure way to search, present, and analyze DICOM data across compatible computing architectures. For primary image diagnosis in Mammography, only uncompressed or non-lossy compressed images must be used. Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. Mobile device display is not intended for diagnostic purposes.
Published
2026-07-13
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
K262120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K262120000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G874AVARAVIEWER0010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological 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.

Regulatory Flags#

DUNS number
939446063
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
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 Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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