FDA.reportPublic FDA data

ASPEN IMAGING HEALTHCARE, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30126248173012624817ASPEN IMAGING HEALTHCARE, INC1N2026-01-01801 north Jupiter rd 200 Plano TX US 75074

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2822531257973357K244049Europa (Alternative: AiRTouch) portable X-ray systemIZL2025-05-28
2822531301860630K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)MQB2024-11-07
2822531874747640K220678APX-24 Portable X-ray SystemIZL2022-03-31
2822531690370201K200022FLUSION-9001, Fluoroscopic C-arm Mobile X-ray SystemOWB2020-04-03
2822531804221151K193644E-COM DR-2000 DRMQB2020-02-14
2822531784473560K180663LaVid FMTS DIAGNOSTIC X-RAY SYSTEMKPR2018-05-18
2822531337671173
2822531771437015

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IZL32025-05-28
MQB22024-11-07
OWB22020-04-03
KPR12018-05-18