FDA Product Code
FDA Product Code IZL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1720
510(k) Clearances — 238 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261943 | REMEX-T(K)100C | Remedi, Inc. | 2026-10-02 | Traditional | PDF ↗ |
| K260236 | XLITE | GEMSS HEALTHCARE CO., LTD. | 2026-08-03 | Traditional | PDF ↗ |
| K253058 | Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-06-18 | Traditional | PDF ↗ |
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO) | DRGEM Corporation | 2026-05-14 | Traditional | PDF ↗ |
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health | 2026-03-11 | Traditional | PDF ↗ |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | Poskom Co., Ltd. | 2026-02-23 | Traditional | PDF ↗ |
| K250976 | Airbile-100 | Poskom Co., Ltd. | 2025-12-19 | Traditional | PDF ↗ |
| K251710 | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | 2025-10-24 | Traditional | PDF ↗ |
| K243864 | BONX805 | Bontech Co., Ltd. | 2025-09-12 | Traditional | PDF ↗ |
| K251443 | PROMO | DRGEM Corporation | 2025-08-22 | Traditional | PDF ↗ |
| K251223 | HnX-P1, HnX-PB | H&abyz Co., Ltd. | 2025-08-04 | Traditional | PDF ↗ |
| K250597 | REMEX Xcam6 | Remedi, Inc. | 2025-07-31 | Traditional | PDF ↗ |
| K243473 | PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS | Prognosys Medical Systems Private Limited | 2025-07-29 | Traditional | PDF ↗ |
| K250750 | INNOVISION-P5 | Dk Medical Systems Co., Ltd. | 2025-07-18 | Traditional | PDF ↗ |
| K244049 | Europa (Alternative: AiRTouch) portable X-ray system | Livermoretech, Inc. | 2025-05-28 | Traditional | PDF ↗ |
| K241980 | !M1 | Solutions For Tomorrow AB | 2025-05-06 | Traditional | PDF ↗ |
| K241996 | ULTRA 1040 | Ecoray Co., Ltd. | 2025-04-18 | Traditional | PDF ↗ |
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | DRGEM Corporation | 2024-12-16 | Traditional | PDF ↗ |
| K241505 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 2024-12-10 | Traditional | PDF ↗ |
| K240841 | Digital Radiography System (ManntiX B, ManntiX K) | Shenzhen Browiner Tech Co., Ltd. | 2024-12-09 | Traditional | PDF ↗ |
| K242515 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2024-10-10 | Traditional | PDF ↗ |
| K242651 | GM85 | Samsung Electronics Co., Ltd. | 2024-10-01 | Special | PDF ↗ |
| K234108 | ERI 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. | 2024-09-20 | Traditional | PDF ↗ |
| K240009 | iQFlex Pro | First Source, Inc. | 2024-07-03 | Traditional | PDF ↗ |
| K240284 | Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) | Shenzhen Browiner Tech Co., Ltd. | 2024-03-28 | Traditional | PDF ↗ |
| K233678 | Radiography 7000 M | Philips Medical Systems Dmc GmbH | 2024-02-14 | Traditional | PDF ↗ |
| K232185 | SM-IV | Sedecal., Sa. | 2023-08-21 | Special | PDF ↗ |
| K230581 | TOPA12 Portable X-ray Unit | Neuf, Inc. | 2023-08-16 | Traditional | PDF ↗ |
| K231577 | MOBILETT Impact | Siemens Medical Solutions | 2023-07-25 | Traditional | PDF ↗ |
| K222896 | AirRay | Poskom Co., Ltd. | 2022-12-20 | Traditional | PDF ↗ |
| K222951 | SM-V | Sedecal., Sa. | 2022-11-21 | Abbreviated | PDF ↗ |
| K222258 | Combined High Frequency X-ray Source | Suzhou Powersite Electric Co., Ltd. | 2022-11-01 | Traditional | PDF ↗ |
| K222339 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2022-09-30 | Traditional | PDF ↗ |
| K222353 | GM85 | Samsung Electronics Co., Ltd. | 2022-09-29 | Traditional | PDF ↗ |
| K221417 | CLAROX plus (Model: VX-100) | Vsi Co., Ltd. | 2022-09-13 | Traditional | PDF ↗ |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | Sedecal., Sa. | 2022-07-18 | Special | PDF ↗ |
| K213405 | MINE ALNU (Model: Mine 2.1) | Hdt Co., Ltd. | 2022-07-10 | Traditional | PDF ↗ |
| K221081 | iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System | First Source, Inc. | 2022-06-13 | Traditional | PDF ↗ |
| K220700 | Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine | Yian Medical Technology (Haining) Co., Ltd. | 2022-05-04 | Traditional | PDF ↗ |
| K220175 | GM85 | Samsung Electronics Co., Ltd. | 2022-04-21 | Traditional | PDF ↗ |
| K220678 | APX-24 Portable X-ray System | Aspenstate, Inc. | 2022-03-31 | Traditional | PDF ↗ |
| K213568 | DRX-Rise Mobile X-ray System | Carestream Health | 2022-03-23 | Traditional | PDF ↗ |
| K212940 | Skanmobile, Skanmobile-Dr | Skanray Technologies Limited | 2022-03-04 | Traditional | PDF ↗ |
| K213462 | EzRay M18 (Model: VMX-P400) | VATECH Co., Ltd. | 2022-02-11 | Traditional | PDF ↗ |
| K212654 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2022-02-04 | Traditional | PDF ↗ |
| K212515 | MOVIX DReamy | Stephanix | 2021-11-03 | Abbreviated | PDF ↗ |
| K212291 | PHOENIX | Sedecal., Sa. | 2021-09-14 | Traditional | PDF ↗ |
| K212134 | Diagnostic X-ray System/PLX5200A | Nanjing Perlove Medical Equipment Co., Ltd. | 2021-08-25 | Traditional | PDF ↗ |
| K211383 | NFLK-2501 Portable X-ray Unit | Neuf, Inc. | 2021-08-13 | Traditional | PDF ↗ |
| K212144 | Remex KA6 | Remedi Co., Ltd. | 2021-08-03 | Traditional | PDF ↗ |
| K211473 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2021-06-04 | Traditional | PDF ↗ |
| K211423 | Rover | Micro-X Limited | 2021-05-21 | Special | PDF ↗ |
| K210982 | AMX Navigate | Ge Medical Systems, LLC | 2021-04-28 | Special | PDF ↗ |
| K203782 | Nanox Cart X-ray System | Nano-X Imaging , Ltd. | 2021-04-01 | Traditional | PDF ↗ |
| K210479 | IMPACT and X-Ranger | Minxray, Inc. | 2021-03-19 | Special | PDF ↗ |
| K203667 | EzRay M (Model: VMX-P300) | VATECH Co., Ltd. | 2021-02-02 | Traditional | PDF ↗ |
| K203658 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2021-01-12 | Traditional | PDF ↗ |
| K202350 | SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021-01-06 | Traditional | PDF ↗ |
| K202353 | SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-12-23 | Traditional | PDF ↗ |
| K201488 | Rover | Micro-X , Ltd. | 2020-07-17 | Abbreviated | PDF ↗ |
| K200637 | SR-8100 Portable X-ray Unit | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-07-09 | Traditional | PDF ↗ |
| K201575 | CMDR 2C (Multiple Models) | Minxray, Inc. | 2020-07-08 | Special | PDF ↗ |
| K201340 | AQUILA 320 D / AQUILA 320 S | Vmi Tecnologias Ltda | 2020-06-19 | Abbreviated | PDF ↗ |
| K200976 | SR-8230, SR-8230S Portable X-ray Unit | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-06-10 | Traditional | PDF ↗ |
| K201124 | TOPAZ Mobile DR System | DRGEM Corporation | 2020-05-19 | Special | PDF ↗ |
| K193535 | EZER, Portable X-ray System | Livermoretech, Inc. | 2020-05-07 | Traditional | PDF ↗ |
| K200726 | AcuityPDR | Radmedix, LLC | 2020-04-13 | Traditional | PDF ↗ |
| K192936 | Soltus 500 | Sedecal., Sa. | 2019-11-15 | Special | PDF ↗ |
| K192011 | PhoeniX | Sedecal., Sa. | 2019-09-25 | Abbreviated | PDF ↗ |
| K191884 | DR 100s | Agfa N.V. | 2019-08-09 | Traditional | PDF ↗ |
| K191813 | MobileDiagnost wDR 2.2 | Sedecal., Sa. | 2019-08-02 | Special | PDF ↗ |
| K191451 | CMDR 2CW (Multiple models) | Minxray, Inc. | 2019-07-03 | Special | PDF ↗ |
| K191025 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 2019-05-17 | Special | PDF ↗ |
| K183292 | Topaz Mobile DR System | DRGEM Corporation | 2019-05-15 | Traditional | PDF ↗ |
| K182639 | MOBILETT Elara Max | Siemens Medi Cal Solutions, Inc. | 2019-03-15 | Traditional | PDF ↗ |
| K183388 | JADE Mobile X-Ray | DRGEM Corporation | 2019-02-05 | Traditional | PDF ↗ |
| K182207 | TR90BH | Minxray, Inc. | 2018-12-14 | Traditional | PDF ↗ |
| K182317 | AMADEO M-DR mini, AMADEO M-AX mini | Oehm Und Rehbein GmbH | 2018-09-24 | Traditional | PDF ↗ |
| K181874 | MX40 Mobile Digital X-ray System | Huestis Machine Corporation | 2018-09-14 | Traditional | PDF ↗ |
| K182234 | Optima XR240amx | Ge Medical Systems, LLC | 2018-09-06 | Special | PDF ↗ |
| K181626 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2018-07-20 | Traditional | PDF ↗ |
| K173924 | DRX-Revolution Nano Mobile X-ray System | Carestream Health, Inc. | 2018-02-05 | Traditional | PDF ↗ |
| K173299 | DRAGON X SPSL4HC, DRAGON X SPSL8HC | Sedecal., Sa. | 2018-01-26 | Special | PDF ↗ |
| K173602 | Optima XR240amx, AutoGrid | Ge Medical Systems, LLC | 2018-01-12 | Traditional | PDF ↗ |
| K173018 | MDR17 Mobile Direct Radiographic System | Del Medical, Inc. | 2017-11-20 | Abbreviated | PDF ↗ |
| K173187 | MobileDiagnost M50 | Philips India Limited | 2017-11-16 | Traditional | PDF ↗ |
| K170607 | !M1 | Solutions For Tomorrow AB | 2017-07-17 | Traditional | PDF ↗ |
| K170755 | DRX-Revolution Nano Mobile X-ray System | Carestream Health, Inc. | 2017-06-21 | Traditional | PDF ↗ |
| K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris | Minxray, Inc. | 2017-06-07 | Special | PDF ↗ |
| K171119 | GM85 | Samsung Electronics Co., Ltd. | 2017-05-12 | Traditional | PDF ↗ |
| K170858 | FDR AQRO (DR-XD 1000) | Fujifilm Medical Systems U.S.A, Inc. | 2017-04-24 | Traditional | PDF ↗ |
| K163063 | UC-5000 Mobile X-Ray | Source-Ray, Inc. | 2016-12-12 | Traditional | PDF ↗ |
| K162278 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2016-11-15 | Traditional | PDF ↗ |
| K162990 | Optima XR240amx | Ge Medical Systems, LLC | 2016-11-15 | Special | PDF ↗ |
| K162687 | Paragon 2 | Meridian Medical Systems, LLC | 2016-10-21 | Traditional | PDF ↗ |
| K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR | Sedecal., Sa. | 2016-07-06 | Special | PDF ↗ |
| K153059 | HF1202H PowerPlus Portable X-ray Equipment | Minxray, Inc. | 2016-02-02 | Special | PDF ↗ |
| K143494 | ADX6000 Portable X-Ray System; iRayA6 | Dexcowin Co., Ltd. | 2015-10-05 | Traditional | PDF ↗ |
| K151038 | EPX-Series Mobile X-ray System | Ecotron Co., Ltd. | 2015-07-24 | Traditional | PDF ↗ |
| K143537 | Sirius Starmobile tiara | Hitachi Medical Systems America, Inc. | 2015-03-06 | Traditional | PDF ↗ |
Product code IZL · Class II · Radiology. Data: openFDA.