Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004063527

FEI Number

3004063527

Entity Name

FIRST SOURCE INC.

City/State/Country

Rochester, NY, US

Establishment Address

3495 Winton Pl Bldg E Ste 1, Rochester, NY 14623, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

First Source Inc (Owner Number: 9056482)

Owner / Operator Contact Address

3495 Winton Place, Building E, Suite 1, Rochester, NY 14623, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

I-Q View IQ Flex M, IQ Flex MD iQ Flex Pro iQ Elevation iQ Panorama

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2022-05-10
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-05-10
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-05-10
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2022-07-12
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2024-09-19
KXH	Cradle, Patient, Radiologic	Radiology	Class 1	892.1830	2023-01-09

Official Correspondent

Ronald Viola

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

First Source 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
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1470-2023	FUJIFILM Healthcare Americas Corporation	2	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024	FUJIFILM Healthcare Americas Corporation	2	The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004063527. Last updated year: 2026. Please use registration number 3004063527 when referencing this establishment in official correspondence.