System, X-ray, Mobile
Product Code: IZL
Radiology Medical Diagnostic X-Ray Equipment
Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]
Code of Federal Regulations: 892.1720
| Radiation Type | Ionizing |
| Radition Safety | Product |
| Annual Reports | Yes |
| K222353 | GM85 | Samsung Electronics Co., LTD. |
| K222339 | UDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. |
| K221803 | PHOENIX/AeroDR TX M01 And PHOENIX/mKDR Xpress. | SEDECAL SA |
| K221417 | CLAROX Plus (Model: VX-100) | VSI Co., Ltd. |
| K220700 | Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine | Yian Medical Technology (Haining) Co., Ltd |
| K220678 | APX-24 Portable X-ray System | Aspenstate INC |
| K220175 | GM85 | Samsung Electronics Co. Ltd. |
| K213568 | DRX-Rise Mobile X-ray System | Carestream Health |
| K213462 | EzRay M18 (Model: VMX-P400) | Vatech Co., Ltd |
| K213405 | MINE ALNU (Model: Mine 2.1) | HDT Co., Ltd |
| K212940 | Skanmobile, Skanmobile-Dr | Skanray Technologies Limited |
| K212654 | Micro C Medical Imaging System, M01 | OXOS Medical, Inc. |
| K212515 | MOVIX DReamy | Stephanix |
| K212144 | Remex KA6 | Remedi Co. Ltd. |
| K212134 | Diagnostic X-ray System/PLX5200A | Nanjing Perlove Medical Equipment Co., Ltd. |
| SYSTEM, X-RAY, MOBILE | CARESTREAM HEALTH, INC. | 2020-03-27 |
| !M1!M1 MODELONE | SOLUTIONS FOR TOMORROW AB | 2020-03-09 |
| | 2020-02-19 |
| OPTIMA PORTABLE RADIOLOGY MACHINE | GE MEDICAL SYSTEMS, LLC | 2020-02-10 |
| PORTABLE X-RAY MACHINE | GE | 2020-02-07 |
| FDR AQRO | FUJIFILM CORPORATION | 2020-02-07 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2020-01-30 |
| GM85 | SAMSUNG ELECTRONICS CO., LTD. | 2020-01-20 |
| MEDTRONIC NAVIGATION | MEDTRONIC NAVIGATION, INC (LITTLETON) | 2020-01-09 |
| MOBILETT ELARA MAX | SIEMENS HEALTHCARE GMBH | 2020-01-06 |
| DRX-REVOLUTION MOBILE X-RAY SYSTEM | CARESTREAM HEALTH INC. | 2019-11-06 |
| OPTIMA XR240AMX | GE MEDICAL SYSTEMS, LLC | 2019-10-24 |
| MEDTRONIC NAVIGATION | MEDTRONIC NAVIGATION, INC (LITTLETON) | 2019-10-02 |
| MOBILETT MIRA MAX | SIEMENS HEALTHCARE GMBH | 2019-09-25 |
| OPTIMA | GE MEDICAL SYSTEMS, LLC | 2019-09-23 |
| OPTIMA | GE MEDICAL SYSTEMS, INC. | 2019-09-16 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2019-08-30 |
| AMX-4 PLUS MOBILE X-RAY SYSTEM | GE MEDICAL SYSTEMS, LLC | 2019-08-21 |
| MOBILETT ELARA MAX | SIEMENS S.A. | 2019-08-12 |
| OPTIMA XR200 | GE MEDICAL SYSTEMS, LLC | 2019-07-29 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2019-07-26 |
| CARESTREAM DRX REVOLUTION MOBILE X-RAY SYSTEM | CARESTREAM HEALTH INC | 2019-07-25 |
| MOBILETT XP HYBRID | SIEMENS HEALTHCARE GMBH | 2019-07-22 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2019-07-11 |
| PHILIPS PORTABLE X-RAY MOBILE DIAGNOST WDR RELEASE 2 | PHILIPS | 2019-06-21 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2019-06-18 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2019-05-06 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2019-04-30 |
| MOBILETT XP HYBRID | SIEMENS HEALTHCARE GMBH | 2019-04-23 |
| MOBILETT MIRA MAX | SIEMENS HEALTHCARE GMBH | 2019-04-19 |
| MOBILETT MIRA MAX | SIEMENS HEALTHCARE GMBH | 2019-04-17 |
| MOBILETT MIRA MAX | SIEMENS HEALTHCARE GMBH | 2019-04-17 |
| AMX-4 PLUS MOBILE X-RAY SYSTEM | GE MEDICAL SYSTEMS | 2019-04-10 |
| MOBILETT XP HYBRID | SIEMENS HEALTHCARE GMBH | 2019-03-27 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2019-03-19 |
| OPTIMA XR240AMX | GE MEDICAL SYSTEMS, LLC | 2019-03-14 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2019-02-27 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2019-01-25 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2019-01-22 |
| CARESTREAM DRX REVOLUTION MOBILE X-RAY SYSTEM | CARESTREAM HEALTH INC | 2019-01-16 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2019-01-09 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2019-01-09 |
| MOBILEDIAGNOST WDR REL. 2 | | 2019-01-09 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2019-01-09 |
| MOBILE DIAGNOSTIC WDR | PHILIPS MEDICAL SYSTEMS, INC. | 2018-12-12 |
| O-ARM IMAGING SYSTEM | | 2018-11-19 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA N.V. | 2018-11-13 |
| DRX-REVOLUTION MOBILE X-RAY SYSTEM | CARESTREAM HEALTH, INC | 2018-10-31 |
| DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 | AGFA HEALTHCARE N.V. | 2018-10-19 |
| PHILIPS | SEDECAL SA | 2018-10-19 |