System, X-Ray, Mobile
Regulation 892.1720
7510(k)s in 12 months (238 all time)
5recalls in 12 months (173 all time)
161recalls that name a 510(k)
Top companies in IZL
| Company | 510(k)s | Recalls |
|---|---|---|
| Sedecal USA, Inc. | 19 | 58 |
| Siemens Medical Solutions | 6 | 18 |
| Carestream Health | 7 | 13 |
| GE Medical Systems | 8 | 10 |
| Minxray, Inc. | 15 | 0 |
| GE Healthcare | 0 | 14 |
| Micro-X , Ltd. | 2 | 10 |
| General X-Ray, Inc. | 11 | 0 |
| Shimadzu Medical Systems | 1 | 8 |
| Samsung Electronics Co., Ltd. | 8 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | SEDECAL SA MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system Open, Classified |
IZL | K111725 K141895 +1 |
| Oct 23, 2025 | SEDECAL SA Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30) Open, Classified |
IZL | K101517 |
| Apr 24, 2025 | Micro-X Ltd. Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number:MXU-RV35
Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-containe Open, Classified |
IZL | K211423 |
| Apr 24, 2025 | Micro-X Ltd. Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number: MXU-RV71, MXU-RV35
Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a se Open, Classified |
IZL | K211423 |
| Apr 16, 2025 | Micro-X Ltd. Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number: MXU-RV35
Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contain Open, Classified |
IZL | K211423 |
| Apr 16, 2025 | Micro-X Ltd. Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number: MXU-RV71
Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contain Open, Classified |
IZL | K211423 |
| Jan 7, 2025 | GE Medical Systems, LLC GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers:
1) 5555000-27;
2) 5555000-31;
3) 5555000-33;
4) 5555000-41;
5) 5555000-47;
6) A0700DL;
7) A1700DA;
8) To be p Open, Classified |
IZL | K162990 K173602 +1 |
| Jan 7, 2025 | GE Medical Systems, LLC GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers:
1) 5555000-12;
2) 5555000-5;
3) 5555000-6;
4) A0659PB;
5) to be provided Open, Classified |
IZL | K103476 K142383 |
| Jan 7, 2025 | GE Medical Systems, LLC GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers:
1) 5555000-3;
2) 5555000-4:
3) A0659MB Open, Classified |
IZL | K103476 K142383 |
| Dec 12, 2024 | Micro-X Ltd. MICRO-X Rover Mobile X-ray System, # MXU-RV35;
MICRO-X Rover Mobile X-ray System, # MXU-RV71 Open, Classified |
IZL | K211423 |
| Dec 12, 2024 | Micro-X Ltd. MICRO-X Rover Mobile X-ray System, # MXU-RV35 Open, Classified |
IZL | K211423 |
| Dec 12, 2024 | Micro-X Ltd. MICRO-X Rover Mobile X-ray System, # MXU-RV19 Open, Classified |
IZL | K211423 |
| Nov 27, 2024 | Micro-X Ltd. MICRO-X Rover Mobile X-ray System, # MXU-RV35 Open, Classified |
IZL | K211423 |
| Sep 25, 2024 | FUJIFILM Healthcare Americas Corporation The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled. Open, Classified |
IZL | K170858 |
| Aug 22, 2024 | NeuroLogica Corporation GM60A. Digital Diagnostic Mobile X-Ray System. Open, Classified |
IZL | K150097 |
| Jul 1, 2024 | First Source Inc First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer. Open, Classified |
IZL | K221081 |
| Jul 1, 2024 | First Source Inc First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer. Open, Classified |
IZL | None listed |
| May 2, 2024 | SEDECAL SA Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers:
a. SM-20HF-Batt;
b. SM-32HF-Batt;
c. SM-40HF-Batt;
d. SM-50HF-Batt;
e. SM-40-HF-B-D-VIR;
f. SM-20HF-B-D-K Open, Classified |
IZL | K161345 |
| Apr 2, 2024 | Agfa N.V. Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generat Open, Classified |
IZL | K103597 |
| Feb 14, 2024 | SEDECAL SA MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 Open, Classified |
IZL | K111725 K141895 +1 |
| Feb 9, 2024 | NeuroLogica Corporation Samsung Digital Diagnostic Mobile X-ray System, Model GM85. Open, Classified |
IZL | K222353 |
| Dec 1, 2023 | Carestream Health, Inc. DRX Revolution Mobile X-Ray System Open, Classified |
IZL | K191025 |
| Nov 14, 2023 | Siemens Medical Solutions USA, Inc Mobilett Mira wireless (VA20) mobile x-ray system(s) Open, Classified |
IZL | K111912 |
| Nov 9, 2023 | Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), im Open, Classified |
IZL | K191025 |
| Jun 30, 2023 | SEDECAL SA wDR 2.2 Mobile Digital Diagnostic X-Ray System Open, Classified |
IZL | K191813 |
| Apr 27, 2023 | FUJIFILM Healthcare Americas Corporation FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and Open, Classified |
IZL | K170858 |
| Apr 19, 2023 | NeuroLogica Corporation Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System Open, Classified |
IZL | K222353 |
| Mar 2, 2023 | SEDECAL SA Phoenix mKDR Xpress, digital mobile diagnostic x-ray system Open, Classified |
IZL | K221803 |
| Mar 2, 2023 | SEDECAL SA Phoenix mKDR, digital mobile diagnostic x-ray system Open, Classified |
IZL | K212291 |
| Nov 4, 2022 | SEDECAL SA Sedecal Soltus
Battery Mobile X-Ray System REF Soltus 450
Battery Mobile X-Ray System REF Soltus 500 Open, Classified |
IZL | K192936 |
| Sep 23, 2022 | Micro-X Ltd. MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 Open, Classified |
IZL | K211423 |
| Sep 29, 2021 | GE Healthcare, LLC AMX Navigate Mobile X-Ray System Terminated |
IZL | K210982 |
| Nov 9, 2020 | Shimadzu Medical Systems Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiogra Open, Classified |
IZL | K080701 |
| Jul 19, 2019 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm FDR Go Plus mobile X-ray system Terminated |
IZL | K080701 |
| May 6, 2019 | NeuroLogica Corporation Samsung GM85 Mobile Digital X-ray Imaging System
Product Usage:
The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained do Terminated |
IZL | K171119 |
| Jan 15, 2019 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm FDR Go PLUS, Mobile X-Ray System
Product Usage:
This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatient Terminated |
IZL | K080701 |
| Jan 14, 2019 | Shimadzu Medical Systems Usa Com SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System
Product Usage:
This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot mov Terminated |
IZL | K080701 |
| Jun 19, 2017 | Carestream Health Inc DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution ---
The DRX-Revolution is a mobile sy Terminated |
IZL | K120062 |
| Mar 29, 2017 | AGFA Healthcare Corp. AGFA Digital Radiography X-Ray System DX-D100
DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis Terminated |
IZL | K103597 |
| Jan 12, 2017 | Carestream Health Inc Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 146 Terminated |
IZL | K120062 |
| Feb 8, 2016 | GE Medical Systems, LLC GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System
Designed to generate diagnostic radiographic images. Terminated |
IZL | K142383 |
| Feb 8, 2016 | GE Medical Systems, LLC GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System
Designed to generate diagnostic radiographic images. Terminated |
IZL | K103476 |
| Feb 8, 2016 | GE Medical Systems, LLC GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System
Designed to generate diagnostic radiographic images. Terminated |
IZL | K142383 |
| Jan 18, 2016 | Sedecal S.A. Mobile wDR motorized portable diagnostic X-ray systems.
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures Terminated |
IZL | K111725 |
| Nov 10, 2015 | Shimadzu Medical Systems Mobile X-ray system MobileDaRt Evolution/FDR Go Software
The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facil Terminated |
IZL | K080701 |
| Aug 14, 2015 | Sedecal S.A. RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray.
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiograp Terminated |
IZL | K101517 |
| Jun 10, 2015 | AGFA Healthcare Corp. AGFA DX-D 100 is a mobile digital radiography x-ray system Terminated |
IZL | K103597 |
| Apr 27, 2015 | GE Healthcare GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx Terminated |
IZL | K142383 |
| Apr 27, 2015 | GE Healthcare GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx Terminated |
IZL | K142383 |
| Apr 27, 2015 | GE Healthcare GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx Terminated |
IZL | K103476 |
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