ClearanceBrief
Panels › Radiology › Product code IZL · Class 2

System, X-Ray, Mobile

Regulation 892.1720

7510(k)s in 12 months (238 all time)
6recalls in 12 months (173 all time)
161recalls that name a 510(k)
Get daily alerts for IZLSample briefCSV

Top companies in IZL

Company510(k)sRecalls
Sedecal USA, Inc.1958
Siemens Medical Solutions618
Carestream Health713
GE Medical Systems810
Minxray, Inc.150
GE Healthcare014
Micro-X , Ltd.210
General X-Ray, Inc.110
Shimadzu Medical Systems18
Samsung Electronics Co., Ltd.80
DateFirm and productCodeLinked 510(k)
Oct 26, 2026Philips North America
Model Number: 712010.
Open, Classified		 IZLK233678
Jul 13, 2026GE Medical Systems, LLC
Optima XR240amx, Mobile Digital Radiographic System
Open, Classified		 IZLK162990
K173602 +1
Jul 13, 2026GE Medical Systems, LLC
Optima XR220amx, Mobile Digital-Ready Radiographic System
Open, Classified		 IZLK103476
K142383
Jul 13, 2026GE Medical Systems, LLC
Optima XR200amx, Mobile Digital-Ready Radiographic System
Open, Classified		 IZLK103476
K142383
Apr 22, 2026Micro-X Ltd.
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Open, Classified		 IZLK211423
Nov 7, 2025NeuroLogica Corporation
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Open, Classified		 IZLK222353
Oct 23, 2025SEDECAL SA
SM_40HF_BDC3, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
SM_40HF_BDC, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
SM_40HF_B_D_VIR3.004, Mobile X-ray system
Open, Classified		 IZLK161345
Oct 23, 2025SEDECAL SA
SM_40HF_B_D_VIR3, Mobile X-ray system
Open, Classified		 IZLK161345
Oct 23, 2025SEDECAL SA
SHIMADZU RF.004, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
SED URS LP, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
RADPRO MOBILE, Mobile X-ray system
Open, Classified		 IZLK161345
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
Open, Classified		 IZLK191813
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number 40KWMOBILE3.899, Mobile X-ray system
Open, Classified		 IZLK090322
Oct 23, 2025SEDECAL SA
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
Open, Classified		 IZLK161345
Oct 23, 2025SEDECAL SA
Model Number 40KWFXPLUS-710CW, Mobile X-ray system
Open, Classified		 IZLK161345
Oct 23, 2025SEDECAL SA
Model Number 40KWFXPLUS.889, Mobile X-ray system
Open, Classified		 IZLK161345
Oct 23, 2025SEDECAL SA
Model Number 40KWFXPLUS.005, Mobile X-ray system
Open, Classified		 IZLK161345
Oct 23, 2025SEDECAL SA
Model Number 40KWFXPLUS.004, Mobile X-ray system
Open, Classified		 IZLK161345
Oct 23, 2025SEDECAL SA
Model Number 40KWFXPLUS.002, Mobile X-ray system
Open, Classified		 IZLK161345
Oct 23, 2025SEDECAL SA
Model Number 40KWFXPLUS, Mobile X-ray system
Open, Classified		 IZLK161345
Oct 23, 2025SEDECAL SA
Model Number 40KW-FX.899, Mobile X-ray system
Open, Classified		 IZLK161345
Oct 23, 2025SEDECAL SA
Model Number 40KWFX, Mobile X-ray system
Open, Classified		 IZLK161345

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.