FDA.reportPublic FDA data

SIMBIOSYS, INC.

Matched from indexed company URL: Simbiosys, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30305982833030598283SIMBIOSYS, INC.1N2026-01-01320 N Sangamon Street Suite 700 Chicago IL US 60607

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860011523901TumorSight Viz - 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+1 872 270 0085support@simbiosys.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3268141389904072K251766TumorSight VizQIH2025-07-08
3268141912590325K231130TumorSight VizQIH2023-12-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QIH22025-07-08

PMN#

GUDID#

TumorSight Viz - 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

Simbiosys, Inc.

2024-06-03