| XLITE (K260236) | GEMSS HEALTHCARE CO., LTD. | 2026-08-03 |
| Portable DR Imaging System (K253058) | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-06-18 |
| RAYMO Mobile X-ray System (Model: RAYMO) (K260085) | DRGEM Corporation | 2026-05-14 |
| Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System (K253185) | Carestream Health | 2026-03-11 |
| AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) (K253244) | Poskom Co., Ltd. | 2026-02-23 |
| Airbile-100 (K250976) | Poskom Co., Ltd. | 2025-12-19 |
| Mobile X-ray unit (!M1) (K251710) | Solutions For Tomorrow AB | 2025-10-24 |
| BONX805 (K243864) | Bontech Co., Ltd. | 2025-09-12 |
| PROMO (K251443) | DRGEM Corporation | 2025-08-22 |
| HnX-P1, HnX-PB (K251223) | H&abyz Co., Ltd. | 2025-08-04 |
| REMEX Xcam6 (K250597) | Remedi, Inc. | 2025-07-31 |
| PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS (K243473) | Prognosys Medical Systems Private Limited | 2025-07-29 |
| INNOVISION-P5 (K250750) | Dk Medical Systems Co., Ltd. | 2025-07-18 |
| Europa (Alternative: AiRTouch) portable X-ray system (K244049) | Livermoretech, Inc. | 2025-05-28 |
| !M1 (K241980) | Solutions For Tomorrow AB | 2025-05-06 |
| ULTRA 1040 (K241996) | Ecoray Co., Ltd. | 2025-04-18 |
| TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) (K242015) | DRGEM Corporation | 2024-12-16 |
| DRX-Revolution Mobile X-ray System (K241505) | Carestream Health, Inc. | 2024-12-10 |
| Digital Radiography System (ManntiX B, ManntiX K) (K240841) | Shenzhen Browiner Tech Co., Ltd. | 2024-12-09 |
| uDR 380i Pro (K242515) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-10-10 |
| GM85 (K242651) | Samsung Electronics Co., Ltd. | 2024-10-01 |
| ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) (K234108) | Energy Resources International Co., Ltd. | 2024-09-20 |
| iQFlex Pro (K240009) | First Source, Inc. | 2024-07-03 |
| Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) (K240284) | Shenzhen Browiner Tech Co., Ltd. | 2024-03-28 |
| Radiography 7000 M (K233678) | Philips Medical Systems Dmc GmbH | 2024-02-14 |
| SM-IV (K232185) | Sedecal., Sa. | 2023-08-21 |
| TOPA12 Portable X-ray Unit (K230581) | Neuf, Inc. | 2023-08-16 |
| MOBILETT Impact (K231577) | Siemens Medical Solutions | 2023-07-25 |
| AirRay (K222896) | Poskom Co., Ltd. | 2022-12-20 |
| SM-V (K222951) | Sedecal., Sa. | 2022-11-21 |
| Combined High Frequency X-ray Source (K222258) | Suzhou Powersite Electric Co., Ltd. | 2022-11-01 |
| uDR 380i Pro (K222339) | Shanghai United Imaging Healthcare Co., Ltd. | 2022-09-30 |
| GM85 (K222353) | Samsung Electronics Co., Ltd. | 2022-09-29 |
| CLAROX plus (Model: VX-100) (K221417) | Vsi Co., Ltd. | 2022-09-13 |
| PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. (K221803) | Sedecal., Sa. | 2022-07-18 |
| MINE ALNU (Model: Mine 2.1) (K213405) | Hdt Co., Ltd. | 2022-07-10 |
| iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System (K221081) | First Source, Inc. | 2022-06-13 |
| Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine (K220700) | Yian Medical Technology (Haining) Co., Ltd. | 2022-05-04 |
| GM85 (K220175) | Samsung Electronics Co., Ltd. | 2022-04-21 |
| APX-24 Portable X-ray System (K220678) | Aspenstate, Inc. | 2022-03-31 |
| DRX-Rise Mobile X-ray System (K213568) | Carestream Health | 2022-03-23 |
| Skanmobile, Skanmobile-Dr (K212940) | Skanray Technologies Limited | 2022-03-04 |
| EzRay M18 (Model: VMX-P400) (K213462) | VATECH Co., Ltd. | 2022-02-11 |
| Micro C Medical Imaging System, M01 (K212654) | Oxos Medical, Inc. | 2022-02-04 |
| MOVIX DReamy (K212515) | Stephanix | 2021-11-03 |
| PHOENIX (K212291) | Sedecal., Sa. | 2021-09-14 |
| Diagnostic X-ray System/PLX5200A (K212134) | Nanjing Perlove Medical Equipment Co., Ltd. | 2021-08-25 |
| NFLK-2501 Portable X-ray Unit (K211383) | Neuf, Inc. | 2021-08-13 |
| Remex KA6 (K212144) | Remedi Co., Ltd. | 2021-08-03 |
| Micro C Medical Imaging System, M01 (K211473) | Oxos Medical, Inc. | 2021-06-04 |
| Rover (K211423) | Micro-X Limited | 2021-05-21 |
| AMX Navigate (K210982) | Ge Medical Systems, LLC | 2021-04-28 |
| Nanox Cart X-ray System (K203782) | Nano-X Imaging , Ltd. | 2021-04-01 |
| IMPACT and X-Ranger (K210479) | Minxray, Inc. | 2021-03-19 |
| EzRay M (Model: VMX-P300) (K203667) | VATECH Co., Ltd. | 2021-02-02 |
| Micro C Medical Imaging System, M01 (K203658) | Oxos Medical, Inc. | 2021-01-12 |
| SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System (K202350) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021-01-06 |
| SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System (K202353) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-12-23 |
| Rover (K201488) | Micro-X , Ltd. | 2020-07-17 |
| SR-8100 Portable X-ray Unit (K200637) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-07-09 |
| CMDR 2C (Multiple Models) (K201575) | Minxray, Inc. | 2020-07-08 |
| AQUILA 320 D / AQUILA 320 S (K201340) | Vmi Tecnologias Ltda | 2020-06-19 |
| SR-8230, SR-8230S Portable X-ray Unit (K200976) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-06-10 |
| TOPAZ Mobile DR System (K201124) | DRGEM Corporation | 2020-05-19 |
| EZER, Portable X-ray System (K193535) | Livermoretech, Inc. | 2020-05-07 |
| AcuityPDR (K200726) | Radmedix, LLC | 2020-04-13 |
| Soltus 500 (K192936) | Sedecal., Sa. | 2019-11-15 |
| PhoeniX (K192011) | Sedecal., Sa. | 2019-09-25 |
| DR 100s (K191884) | Agfa N.V. | 2019-08-09 |
| MobileDiagnost wDR 2.2 (K191813) | Sedecal., Sa. | 2019-08-02 |
| CMDR 2CW (Multiple models) (K191451) | Minxray, Inc. | 2019-07-03 |
| DRX-Revolution Mobile X-ray System (K191025) | Carestream Health, Inc. | 2019-05-17 |
| Topaz Mobile DR System (K183292) | DRGEM Corporation | 2019-05-15 |
| MOBILETT Elara Max (K182639) | Siemens Medi Cal Solutions, Inc. | 2019-03-15 |
| JADE Mobile X-Ray (K183388) | DRGEM Corporation | 2019-02-05 |
| TR90BH (K182207) | Minxray, Inc. | 2018-12-14 |
| AMADEO M-DR mini, AMADEO M-AX mini (K182317) | Oehm Und Rehbein GmbH | 2018-09-24 |
| MX40 Mobile Digital X-ray System (K181874) | Huestis Machine Corporation | 2018-09-14 |
| Optima XR240amx (K182234) | Ge Medical Systems, LLC | 2018-09-06 |
| Digital Diagnostic Mobile X-ray System (K181626) | Samsung Electronics Co., Ltd. | 2018-07-20 |
| DRX-Revolution Nano Mobile X-ray System (K173924) | Carestream Health, Inc. | 2018-02-05 |
| DRAGON X SPSL4HC, DRAGON X SPSL8HC (K173299) | Sedecal., Sa. | 2018-01-26 |
| Optima XR240amx, AutoGrid (K173602) | Ge Medical Systems, LLC | 2018-01-12 |
| MDR17 Mobile Direct Radiographic System (K173018) | Del Medical, Inc. | 2017-11-20 |
| MobileDiagnost M50 (K173187) | Philips India Limited | 2017-11-16 |
| !M1 (K170607) | Solutions For Tomorrow AB | 2017-07-17 |
| DRX-Revolution Nano Mobile X-ray System (K170755) | Carestream Health, Inc. | 2017-06-21 |
| CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris (K171353) | Minxray, Inc. | 2017-06-07 |
| GM85 (K171119) | Samsung Electronics Co., Ltd. | 2017-05-12 |
| FDR AQRO (DR-XD 1000) (K170858) | Fujifilm Medical Systems U.S.A, Inc. | 2017-04-24 |
| UC-5000 Mobile X-Ray (K163063) | Source-Ray, Inc. | 2016-12-12 |
| Digital Diagnostic Mobile X-ray System (K162278) | Samsung Electronics Co., Ltd. | 2016-11-15 |
| Optima XR240amx (K162990) | Ge Medical Systems, LLC | 2016-11-15 |
| Paragon 2 (K162687) | Meridian Medical Systems, LLC | 2016-10-21 |
| RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR (K161345) | Sedecal., Sa. | 2016-07-06 |
| HF1202H PowerPlus Portable X-ray Equipment (K153059) | Minxray, Inc. | 2016-02-02 |
| ADX6000 Portable X-Ray System; iRayA6 (K143494) | Dexcowin Co., Ltd. | 2015-10-05 |
| EPX-Series Mobile X-ray System (K151038) | Ecotron Co., Ltd. | 2015-07-24 |
| Sirius Starmobile tiara (K143537) | Hitachi Medical Systems America, Inc. | 2015-03-06 |
| GM60A-32S & GM60A-40S (K150097) | Samsung Electronics Co., Ltd. | 2015-02-19 |