Data / Medical devices / United States / Aspen Imaging Healthcare, Inc

Aspen Imaging Healthcare, Inc: FDA-registered device maker in Plano, TX, United States, 5 510(k) clearances

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

Aspen Imaging Healthcare, Inc is registered with the FDA (registration 3012624817) in Plano, TX, United States. It lists 9 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 28, 2025. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Aspen Imaging Healthcare, Inc

FDA registration number: 3012624817
Address: 801 north Jupiter rd 200, Plano, TX, United States, 75074
Owner or operator: ASPEN IMAGING HEALTHCARE, INC (10051160)
Roles: Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler
First device listed: November 5, 2020
Registered through: 2026
Brand names listed: APX-24 Portable X-ray System, ASPENVUE, ASPENXDR, AsepenVue, AspenFDR; AspenUDR; AspenXDR, EUROPA85, EUROPA85L, EUROPA90, EUROPA90L- Portable X-Ray System, FLUSION 9001 - Fluoroscopic C-Arm Mobile X- Ray System

Devices it lists

Device	Product code	Class	Role	Source
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Manufacturer	accessdata.fda.gov
Tube Mount, X-Ray, Diagnostic	IYB	1	Manufacturer, Remanufacturer, Repackager or relabeler	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
May 28, 2025	K244049	Europa (Alternative: AiRTouch) portable X-ray system	IZL	Substantially Equivalent	Livermoretech, Inc.	accessdata.fda.gov
March 31, 2022	K220678	APX-24 Portable X-ray System	IZL	Substantially Equivalent	Aspenstate, Inc.	accessdata.fda.gov
April 3, 2020	K200022	FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System	OWB	Substantially Equivalent	Livermoretech, Inc.	accessdata.fda.gov
February 14, 2020	K193644	E-COM DR-2000 DR	MQB	Substantially Equivalent	Livermoretech, Inc.	accessdata.fda.gov
May 18, 2018	K180663	LaVid FMTS DIAGNOSTIC X-RAY SYSTEM	KPR	Substantially Equivalent	Livermoretech, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 28, 2025. 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.