FDA.reportPublic FDA data

Alex Lee

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30299160613029916061Alex Lee1N2026-01-0113755 HUTTON DR Suite 500 Farmers Branch TX US 75234

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3201211912333739K260085RAYMO Mobile X-ray System (Model: RAYMO)IZL2026-05-14
3201211490910495K251443PROMOIZL2025-08-22
3201212058677621K242019GXR-Series Diagnostic X-Ray SystemKPR2025-01-07
3201212030050936K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)IZL2024-12-16
3201211585995410K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)KPR2023-09-19
3201211222102652K202572GXR-Series Diagnostic X-Ray SystemKPR2020-09-24
3201211755098539K202156DIAMOND-5A/6A/8AKPR2020-09-10
3201211132136410K201124TOPAZ Mobile DR SystemIZL2020-05-19
3201211631231221K192453DIAMOND-5A/6A/8AKPR2019-10-01
3201212071422516K183388JADE Mobile X-RayIZL2019-02-05
3201211527340881K182537RADMAX Digital Imaging SoftwareLLZ2019-03-08
3201211011762832
3201211068111374
3201211449194465
3201211451521739
3201211760429243
3201211836335868
3201211882006716

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IZL52026-05-14
KPR52025-01-07
LLZ12019-03-08