SIMBIOSYS, INC.

FDA Device Registration & Listing · Chicago, IL, US · Registration 3030598283

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030598283
FEI Number
3030598283
Entity Name
SIMBIOSYS, INC.
City/State/Country
Chicago, IL, US
Establishment Address
320 N Sangamon Street, Suite 700, Chicago, IL 60607, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SimBioSys, Inc. (Owner Number: 10090319)
Owner / Operator Contact Address
320 N Sangamon Street, Suite 700, Chicago, IL 60607, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231130
PMA Number
N/A

All Registered Proprietary Names

TumorSight Viz

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-03-12

Official Correspondent

Joseph Peterson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SimBioSys, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030598283. Last updated year: 2026. Please use registration number 3030598283 when referencing this establishment in official correspondence.
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