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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)
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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
Decided510(k)Device and applicantCode
Oct 2, 2026K261943REMEX-T(K)100C
Remedi, Inc., KR
IZL
Aug 3, 2026K260236XLITE
GEMSS HEALTHCARE CO., LTD., KR
IZL
Jun 18, 2026K253058Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd., CN
IZL
May 14, 2026K260085RAYMO Mobile X-ray System (Model: RAYMO)
DRGEM Corporation, KR
IZL
Mar 11, 2026K253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
Carestream Health
IZL
Feb 23, 2026K253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
Poskom Co., Ltd., KR
IZL
Dec 19, 2025K250976Airbile-100
Poskom Co., Ltd., KR
IZL
Oct 24, 2025K251710Mobile X-ray unit (!M1)
Solutions For Tomorrow AB, SE
IZL
Sep 12, 2025K243864BONX805
Bontech Co., Ltd., KR
IZL
Aug 22, 2025K251443PROMO
DRGEM Corporation, KR
IZL
Aug 4, 2025K251223HnX-P1, HnX-PB
H&abyz Co., Ltd., KR
IZL
Jul 31, 2025K250597REMEX Xcam6
Remedi, Inc., KR
IZL
Jul 29, 2025K243473PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS
Prognosys Medical Systems Private Limited, IN
IZL
Jul 18, 2025K250750INNOVISION-P5
Dk Medical Systems Co., Ltd., KR
IZL
May 28, 2025K244049Europa (Alternative: AiRTouch) portable X-ray system
Livermoretech, Inc.
IZL
May 6, 2025K241980!M1
Solutions For Tomorrow AB, SE
IZL
Apr 18, 2025K241996ULTRA 1040
Ecoray Co., Ltd., KR
IZL
Dec 16, 2024K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
DRGEM Corporation, KR
IZL
Dec 10, 2024K241505DRX-Revolution Mobile X-ray System
Carestream Health, Inc.
IZL
Dec 9, 2024K240841Digital Radiography System (ManntiX B, ManntiX K)
Shenzhen Browiner Tech Co., Ltd., CN
IZL
Oct 10, 2024K242515uDR 380i Pro
Shanghai United Imaging Healthcare Co., Ltd., CN
IZL
Oct 1, 2024K242651GM85
Samsung Electronics Co., Ltd., KR
IZL
Sep 20, 2024K234108ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)
Energy Resources International Co., Ltd., TW
IZL
Jul 3, 2024K240009iQFlex Pro
First Source, Inc.
IZL
Mar 28, 2024K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)
Shenzhen Browiner Tech Co., Ltd., CN
IZL
Feb 14, 2024K233678Radiography 7000 M
Philips Medical Systems Dmc GmbH, DE
IZL
Aug 21, 2023K232185SM-IV
Sedecal., Sa., ES
IZL
Aug 16, 2023K230581TOPA12 Portable X-ray Unit
Neuf, Inc., KR
IZL
Jul 25, 2023K231577MOBILETT Impact
Siemens Medical Solutions
IZL
Dec 20, 2022K222896AirRay
Poskom Co., Ltd., KR
IZL
Nov 21, 2022K222951SM-V
Sedecal., Sa., ES
IZL
Nov 1, 2022K222258Combined High Frequency X-ray Source
Suzhou Powersite Electric Co., Ltd., CN
IZL
Sep 30, 2022K222339uDR 380i Pro
Shanghai United Imaging Healthcare Co., Ltd., CN
IZL
Sep 29, 2022K222353GM85
Samsung Electronics Co., Ltd., KR
IZL
Sep 13, 2022K221417CLAROX plus (Model: VX-100)
Vsi Co., Ltd., KR
IZL
Jul 18, 2022K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.
Sedecal., Sa., ES
IZL
Jul 10, 2022K213405MINE ALNU (Model: Mine 2.1)
Hdt Co., Ltd., KR
IZL
Jun 13, 2022K221081iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
First Source, Inc.
IZL
May 4, 2022K220700Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine
Yian Medical Technology (Haining) Co., Ltd., CN
IZL
Apr 21, 2022K220175GM85
Samsung Electronics Co., Ltd., KR
IZL
Mar 31, 2022K220678APX-24 Portable X-ray System
Aspenstate, Inc.
IZL
Mar 23, 2022K213568DRX-Rise Mobile X-ray System
Carestream Health
IZL
Mar 4, 2022K212940Skanmobile, Skanmobile-Dr
Skanray Technologies Limited, IN
IZL
Feb 11, 2022K213462EzRay M18 (Model: VMX-P400)
VATECH Co., Ltd., KR
IZL
Feb 4, 2022K212654Micro C Medical Imaging System, M01
Oxos Medical, Inc.
IZL
Nov 3, 2021K212515MOVIX DReamy
Stephanix, FR
IZL
Sep 14, 2021K212291PHOENIX
Sedecal., Sa., ES
IZL
Aug 25, 2021K212134Diagnostic X-ray System/PLX5200A
Nanjing Perlove Medical Equipment Co., Ltd., CN
IZL
Aug 13, 2021K211383NFLK-2501 Portable X-ray Unit
Neuf, Inc., KR
IZL
Aug 3, 2021K212144Remex KA6
Remedi Co., Ltd., KR
IZL

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