Mosaic Viewer

Primary DI
00862234000337
Brand
Mosaic Viewer
Company
Virtual Radiologic Corporation
Model
1
Device description
The Mosaic Viewer software is used with general purpose computing hardware which meets or exceeds minimum specifications. The Viewer is intended to receive, display, and transmit images for clinical purposes. It is intended for installation on a PC meeting or exceeding minimum specifications and networked with storage components. It is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. It can process medical images from DICOM modalities, such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM-compliant modalities. Mosaic Viewer may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM "For Presentation" format and may only be used on monitors determined to be appropriate for the desired task.
Published
2026-07-31
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

Contact Domains#

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
K241879000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241879000vRad ViewerVirtual Radiologic Corporation2024-07-18LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862234000337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862234000337008622340003378622340003370862234000337

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Contacts#

Phone, Email table
PhoneEmail
952-5951198ogc@vrad.com

Regulatory Flags#

DUNS number
133841267
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
00862234000306vRad PACS12016-09-22
00862234000313vRad PACS22016-11-18
00862234000320vRad Viewer12026-02-13

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