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First Source Inc.: FDA-registered device maker in Rochester, NY, United States, 3 510(k) clearances

Name: First Source Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

First Source Inc. is registered with the FDA (registration 3004063527) in Rochester, NY, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 3, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004063527
Address: 3495 Winton Pl Bldg E Ste 1, Rochester, NY, United States, 14623
Owner or operator: First Source Inc (9056482)
Roles: Manufacturer, Specification developer
First device listed: May 10, 2022
Registered through: 2026
Brand names listed: I-Q View, IQ Flex M, IQ Flex MD, iQ Elevation, iQ Flex Pro, iQ Panorama

Devices it lists

Device	Product code	Class	Role	Source
Cradle, Patient, Radiologic	KXH	1	Manufacturer	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Specification developer	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 3, 2024	K240009	iQFlex Pro	IZL	Substantially Equivalent	First Source, Inc.	accessdata.fda.gov
June 13, 2022	K221081	iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System	IZL	Substantially Equivalent	First Source, Inc.	accessdata.fda.gov
March 24, 2021	K203703	I-Q View	MQB	Substantially Equivalent	First Source, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 9, 2024	94744	Class II	Ongoing	First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.	Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.	accessdata.fda.gov

Compare with other makers

Updated July 3, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.