Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3045078825

FEI Number

3045078825

Entity Name

Voronoi Health Analytics Inc

City/State/Country

Vancouver British Columbia, CA

Establishment Address

997 Seymour St #250, Vancouver British Columbia V6B 3M1, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Voronoi Health Analytics Incorporated (Owner Number: 10095478)

Owner / Operator Contact Address

997 Seymour St #250, Vancouver, CA-BC V6B 3M1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253944

PMA Number

N/A

All Registered Proprietary Names

Data Analysis Facilitation Suite Data Analysis Facilitation Suite (DAFS) DAFS

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	2026-03-17

Official Correspondent

Karteek Popuri

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Voronoi Health Analytics Incorporated

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 3045078825. Last updated year: 2026. Please use registration number 3045078825 when referencing this establishment in official correspondence.