| DRE Duo (K260482) | Jpi Healthcare Co, Ltd. | 2026-06-15 |
| AeroDR TX c02 (K253446) | Dk Medical Systems Co., Ltd. | 2026-04-10 |
| DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector (K250954) | Carestream Health | 2026-01-20 |
| uDR Arria & uDR Aris (K252000) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-11-26 |
| uDR Aurora CX (K251167) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-19 |
| Definium Tempo Select (K250788) | Ge Hualun Medical Systems Co. , Ltd. | 2025-08-28 |
| INNOVISION-DXII (K250790) | Dk Medical Systems Co., Ltd. | 2025-08-01 |
| YSIO X.pree (K250738) | Siemens Medical Solutions | 2025-07-31 |
| GXR-Series Diagnostic X-Ray System (K242019) | DRGEM Corporation | 2025-01-07 |
| Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (K242499) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. | 2025-01-06 |
| INNOVISION-EXII (K242119) | Dk Medical System | 2025-01-03 |
| uDR 780i (K241068) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-11-01 |
| EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); (K242847) | DRTECH Corporation | 2024-10-23 |
| Definium Pace Select ET (K242678) | Ge Hualun Medical Systems Co. , Ltd. | 2024-10-01 |
| GF85 (models GF85-3P, GF85-SP) (K242478) | Samsung Electronics Co., Ltd. | 2024-09-19 |
| EOSedge (K233920) | Eos Imaging | 2024-08-06 |
| EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM) (K233530) | DRTECH Corporation | 2024-07-26 |
| Radiography 7300 C (K233662) | Philips Medical Systems Dmc GmbH | 2024-06-13 |
| YSIO X.pree (K233543) | Siemens Medical Solutions | 2024-05-21 |
| FDR Visionary Suite (K233719) | Shimadzu Corporation | 2024-03-28 |
| DRX-Evolution Plus System (K233381) | Carestream Health, Inc. | 2024-03-12 |
| RADspeed Pro (K233722) | Shimadzu Corporation | 2024-02-23 |
| MULTIX Impact E (K233532) | Siemens Medical Solutions | 2023-11-29 |
| XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 (K230800) | GEMSS HEALTHCARE CO., LTD. | 2023-11-02 |
| PodSKAN HF Diagnostic X-ray System (K231761) | Skanray Technologies Limited | 2023-10-27 |
| AcuityUDR (K231995) | Radmedix, LLC | 2023-10-25 |
| GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) (K232178) | DRGEM Corporation | 2023-09-19 |
| Definium Pace Select (K231892) | Ge Hualun Medical Systems Co. , Ltd. | 2023-09-12 |
| DMX (K223550) | Del Medical, Inc. | 2023-04-10 |
| Jumong General (K230241) | Sg Healthcare Co, Ltd. | 2023-02-23 |
| DRX - Compass (K223842) | Carestream Health, Inc. | 2023-01-20 |
| DigiX FDX (K223060) | Allengers Medical Systems Limited | 2022-10-26 |
| OTC DDR (K221853) | Konica Minolta Healthcare Americas, Inc. | 2022-07-27 |
| MULTIX Impact E (K220919) | Siemens Medical Solutions USA, Inc. | 2022-05-17 |
| Hand Diagnostic Radiography Imaging System (K220271) | Nanoray Biotech Co., Ltd. | 2022-04-29 |
| General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) (K220149) | Xera Medical Systems & Technology , Ltd. | 2022-04-19 |
| SKANRAD 400 (K220518) | Skanray Technologies Limited | 2022-04-01 |
| ExamVue Duo (K213057) | Jpi Healthcare Co, Ltd. | 2022-02-18 |
| Straight Arm DDR (K214012) | Konica Minolta Healthcare Americas, Inc. | 2022-01-12 |
| MULTIX Impact, MULTIX Impact C (K213700) | Siemens Medical Solutions USA, Inc. | 2021-12-13 |
| Philips Radiology Smart Assistant (K212186) | Philips Medical Systems Dmc GmbH | 2021-12-13 |
| DigitalDiagnost (K210692) | Philips Medical Systems Dmc GmbH | 2021-04-02 |
| Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems (K203537) | Sedecal., Sa. | 2021-02-01 |
| MULTIX Impact (K203345) | Siemens Medical Solutions USA, Inc. | 2021-01-07 |
| MULTIX Impact C (K203340) | Siemens Medical Solutions USA, Inc. | 2021-01-06 |
| Apolo D / Apolo S (K202388) | Vmi Tecnologias Ltda | 2020-12-01 |
| MiniCAT 2D (K201825) | Xoran Technologies, LLC | 2020-11-20 |
| YSIO X.pree (K201670) | Siemens Medical Solutions USA, Inc. | 2020-10-21 |
| Radiographic System Challenge X (K202293) | Sedecal., Sa. | 2020-10-07 |
| GXR-Series Diagnostic X-Ray System (K202572) | DRGEM Corporation | 2020-09-24 |
| EOSedge (K202394) | Eos Imaging | 2020-09-16 |
| DIAMOND-5A/6A/8A (K202156) | DRGEM Corporation | 2020-09-10 |
| DigitalDiagnost C50 (K201725) | Philips Healthcare (Suzhou) Co., Lit. | 2020-07-10 |
| DuraDiagnost (K201640) | Philips Healthcare (Suzhou) Co., Ltd. | 2020-07-09 |
| DRX-Compass (K201373) | Carestream Health, Inc. | 2020-06-26 |
| UNIEXPERT 2 PLUS (K200944) | Adani | 2020-05-26 |
| MULTIX Impact (K193089) | Siemens Medical Solutions USA, Inc. | 2020-03-20 |
| MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System (K193637) | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2020-01-28 |
| Q-Rad System (K193574) | Carestream Health, Inc. | 2020-01-22 |
| KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography (K193225) | Konica Minolta Healthcare Americas, Inc. | 2020-01-15 |
| Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard (K193360) | Radmedix, LLC | 2020-01-02 |
| DRX-Evolution with Carestream Digital Tomosynthesis (K191879) | Carestream Health, Inc. | 2019-12-20 |
| EOSedge (K192079) | Eos Imaging | 2019-11-27 |
| DRX-Evolution/Plus with Dual Energy (K190330) | Carestream Health, Inc. | 2019-11-04 |
| DigiX FDX (K192541) | Allengers Medical Systems Limited | 2019-10-16 |
| DIAMOND-5A/6A/8A (K192453) | DRGEM Corporation | 2019-10-01 |
| GXR-Series Diagnostic X-Ray System (K192364) | DRGEM Corporation | 2019-09-26 |
| uDR 592h, uDR 596i (K192293) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-09-12 |
| Discovery XR656 HD with VolumeRad (K191699) | Ge Hualun Medical Systems Co. , Ltd. | 2019-07-24 |
| Multix Fusion Max (K191418) | Siemens Medical Solutions USA, Inc. | 2019-06-19 |
| MasteRad MX30 (K190601) | Medicatech USA | 2019-04-25 |
| ProRad 2FC and ProRad 3NC Stationary Radiographic Systems (K183541) | Prognosys Medical Systems Private Limited | 2019-01-24 |
| MULTIX Impact (K182517) | Siemens Medi Cal Solutions, Inc. | 2019-01-11 |
| GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A (K182183) | Samsung Electronics Co., Ltd. | 2018-12-07 |
| ARiX RAD Radiographic System (K182134) | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2018-11-26 |
| Halifax Imaging Kit (K182880) | Halifax Biomedical, Inc. | 2018-10-31 |
| GC70 (K182647) | Samsung Electronics Co., Ltd. | 2018-10-24 |
| GU60A, GU60A-65 (K182622) | Samsung Electronics Co., Ltd. | 2018-10-23 |
| GC85A (K181629) | Samsung Electronics Co., Ltd. | 2018-07-20 |
| uDR 592h, uDR 596i (K181413) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-27 |
| Ysio Max (K181279) | Siemens Medi Cal Solutions, Inc. | 2018-06-13 |
| GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 (K180543) | Samsung Electronics Co., Ltd. | 2018-05-24 |
| LaVid FMTS DIAGNOSTIC X-RAY SYSTEM (K180663) | Livermoretech, Inc. | 2018-05-18 |
| Televere Podiatry X-Ray System HF (K180765) | Televere Systems, Inc. | 2018-04-20 |
| RADspeed fit (K173517) | Shimadzu Corporation | 2018-03-30 |
| Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System (K173823) | Summit Industries, LLC | 2018-02-09 |
| uDR 780i (K173953) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-01-26 |
| GU60A & GU60A-65 (K173828) | Samsung Electronics Co., Ltd. | 2018-01-12 |
| Optima XR646 HD (K173612) | Ge Hualun Medical Systems Co. , Ltd. | 2017-12-11 |
| GC85A (K172229) | Samsung Electronics Co., Ltd. | 2017-11-22 |
| Discovery XR656 HD (K172869) | Ge Hualun Medical Systems Co. , Ltd. | 2017-10-20 |
| DigiX FDX (K162529) | Allengers Medical Systems Limited | 2017-03-03 |
| HF 718BD X-Ray System (K160857) | Arquilla, Inc. Dba X-Cel X-Ray Corporation | 2017-02-24 |
| DigitalDiagnost C50 (K163410) | Philips Healthcare (Suzhou) Co., Ltd. | 2017-01-04 |
| Carestream DRX-Evolution (K163203) | Carestream Health, Inc. | 2016-12-13 |
| GC70 (K163115) | Samsung Electronics Co., Ltd. | 2016-12-07 |
| FS-500DDR Medical Radiographic X-Ray System (K152813) | Orich Medical Equipment (Tianjin) Co., Ltd. | 2016-12-02 |
| Multix Fusion Max (K162971) | Siemens Medical Solutions USA, Inc. | 2016-11-22 |
| CuattroDR (K161937) | Cuattro, LLC | 2016-10-06 |
| ArtPix Mobile EZ2GO (K162224) | Cmt Medical Technologies, Ltd. | 2016-09-22 |