FDA.reportPublic FDA data

TumorSight Viz

Primary DI
00860011523901
Brand
TumorSight Viz
Company
Simbiosys, Inc.
Model
V1.1
Device description
TumorSight Viz is an image processing system designed to assist in the visualization and analysis, of breast DCE-MRI studies.TumorSight reads DICOM magnetic resonance images. TumorSight processes and displays the results on the TumorSight web application.Available features support:1) Visualization (standard image viewing tools, MIPs, and reformats)2) Analysis (registration, subtractions, kinetic curves, parametric image maps, segmentation and 3D volume rendering)The TumorSight system consists of proprietary software developed by SimBioSys, Inc. hosted on a cloud-based platform and accessed on an off-the-shelf computer
Published
2024-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231130000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231130000TumorSight VizSimBioSys, Inc.2023-12-26QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011523901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011523901008600115239018600115239010860011523901

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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 872 270 0085support@simbiosys.com

Regulatory Flags#

DUNS number
080409441
Device count
1
Lot or batch
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
B720BX360HYPERDENSI1440Brainomix 360 HyperdensityBRAINOMIX LIMITEDQIH2026-09-18
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
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08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18