Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012624817

FEI Number

3012624817

Entity Name

ASPEN IMAGING HEALTHCARE, INC

City/State/Country

Plano, TX, US

Establishment Address

801 north Jupiter rd, 200, Plano, TX 75074, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

ASPEN IMAGING HEALTHCARE, INC (Owner Number: 10051160)

Owner / Operator Contact Address

801 Jupiter Rd, Suite 200, 200, Plano, TX 75074, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220678

PMA Number

N/A

All Registered Proprietary Names

ASPENXDR IODR1417-GF IODR1417 IODR1717 AsepenVue ASPENVUE AsepenVue FLUSION 9001 - Fluoroscopic C-Arm Mobile X- Ray System AspenFDR; AspenUDR; AspenXDR FLUSION 9001 - Fluoroscopic C-Arm Mobile X- Ray System APX-24 Portable X-ray System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	2020-11-05
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2025-02-04
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2020-12-07
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-11-19
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2020-12-07
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2020-11-19
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2020-11-19
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2020-11-19
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2020-11-19
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2026-03-26
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2020-11-19
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2020-11-19
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2020-11-19
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2020-11-19
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2022-04-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ASPEN IMAGING HEALTHCARE, 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
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
K163715	Philips Medical Systems Nederland B.V.	Allura Xper R9	2017-01-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0001-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0002-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0003-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Similar Registrations

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1225677	UMI INTL.	Norwood, NJ, US
8030233	SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION	KYOTO, JP
3012569470	VISARIS D.O.O.	Zemun Beograd, RS
2243057	Accogent Pausch	Tinton Falls, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012624817. Last updated year: 2026. Please use registration number 3012624817 when referencing this establishment in official correspondence.