Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KPR — Predicate Candidate Screening
356 FDA 510(k) clearances under this product code; the 50 most recent screened below.
57 daysmedian FDA review time
202 days90th percentile
356clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260482 | DRE Duo | Jpi Healthcare Co, Ltd. | 2026-06-15 | 122 | 0 |
| K253446 | AeroDR TX c02 | Dk Medical Systems Co., Ltd. | 2026-04-10 | 190 | 0 |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray Sy | Carestream Health | 2026-01-20 | 298 | 0 |
| K252000 | uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. | 2025-11-26 | 152 | 0 |
| K251167 | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-19 | 157 | 0 |
| K250788 | Definium Tempo Select | Ge Hualun Medical Systems Co. , Ltd. | 2025-08-28 | 167 | 0 |
| K250790 | INNOVISION-DXII | Dk Medical Systems Co., Ltd. | 2025-08-01 | 140 | 0 |
| K250738 | YSIO X.pree | Siemens Medical Solutions | 2025-07-31 | 142 | 0 |
| K242019 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2025-01-07 | 181 | 0 |
| K242499 | Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU30 | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. | 2025-01-06 | 137 | 0 |
| K242119 | INNOVISION-EXII | Dk Medical System | 2025-01-03 | 168 | 0 |
| K241068 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | 2024-11-01 | 196 | 0 |
| K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A4 | DRTECH Corporation | 2024-10-23 | 33 | 0 |
| K242678 | Definium Pace Select ET | Ge Hualun Medical Systems Co. , Ltd. | 2024-10-01 | 25 | 0 |
| K242478 | GF85 (models GF85-3P, GF85-SP) | Samsung Electronics Co., Ltd. | 2024-09-19 | 29 | 0 |
| K233920 | EOSedge | Eos Imaging | 2024-08-06 | 237 | 0 |
| K233530 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A4 | DRTECH Corporation | 2024-07-26 | 267 | 0 |
| K233662 | Radiography 7300 C | Philips Medical Systems Dmc GmbH | 2024-06-13 | 211 | 1 |
| K233543 | YSIO X.pree | Siemens Medical Solutions | 2024-05-21 | 200 | 0 |
| K233719 | FDR Visionary Suite | Shimadzu Corporation | 2024-03-28 | 128 | 0 |
| K233381 | DRX-Evolution Plus System | Carestream Health, Inc. | 2024-03-12 | 162 | 0 |
| K233722 | RADspeed Pro | Shimadzu Corporation | 2024-02-23 | 94 | 1 |
| K233532 | MULTIX Impact E | Siemens Medical Solutions | 2023-11-29 | 27 | 0 |
| K230800 | XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN- | GEMSS HEALTHCARE CO., LTD. | 2023-11-02 | 224 | 0 |
| K231761 | PodSKAN HF Diagnostic X-ray System | Skanray Technologies Limited | 2023-10-27 | 133 | 0 |
| K231995 | AcuityUDR | Radmedix, LLC | 2023-10-25 | 112 | 0 |
| K232178 | GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, G | DRGEM Corporation | 2023-09-19 | 57 | 0 |
| K231892 | Definium Pace Select | Ge Hualun Medical Systems Co. , Ltd. | 2023-09-12 | 76 | 1 |
| K223550 | DMX | Del Medical, Inc. | 2023-04-10 | 136 | 0 |
| K230241 | Jumong General | Sg Healthcare Co, Ltd. | 2023-02-23 | 24 | 0 |
| K223842 | DRX - Compass | Carestream Health, Inc. | 2023-01-20 | 29 | 0 |
| K223060 | DigiX FDX | Allengers Medical Systems Limited | 2022-10-26 | 26 | 0 |
| K221853 | OTC DDR | Konica Minolta Healthcare Americas, Inc. | 2022-07-27 | 30 | 0 |
| K220919 | MULTIX Impact E | Siemens Medical Solutions USA, Inc. | 2022-05-17 | 48 | 0 |
| K220271 | Hand Diagnostic Radiography Imaging System | Nanoray Biotech Co., Ltd. | 2022-04-29 | 88 | 0 |
| K220149 | General Radiography X-ray System (Model: GR10X 40K), General | Xera Medical Systems & Technology , Ltd. | 2022-04-19 | 90 | 0 |
| K220518 | SKANRAD 400 | Skanray Technologies Limited | 2022-04-01 | 37 | 0 |
| K213057 | ExamVue Duo | Jpi Healthcare Co, Ltd. | 2022-02-18 | 149 | 0 |
| K214012 | Straight Arm DDR | Konica Minolta Healthcare Americas, Inc. | 2022-01-12 | 21 | 0 |
| K213700 | MULTIX Impact, MULTIX Impact C | Siemens Medical Solutions USA, Inc. | 2021-12-13 | 20 | 0 |
| K212186 | Philips Radiology Smart Assistant | Philips Medical Systems Dmc GmbH | 2021-12-13 | 153 | 0 |
| K210692 | DigitalDiagnost | Philips Medical Systems Dmc GmbH | 2021-04-02 | 25 | 8 |
| K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Ra | Sedecal., Sa. | 2021-02-01 | 60 | 0 |
| K203345 | MULTIX Impact | Siemens Medical Solutions USA, Inc. | 2021-01-07 | 55 | 0 |
| K203340 | MULTIX Impact C | Siemens Medical Solutions USA, Inc. | 2021-01-06 | 55 | 0 |
| K202388 | Apolo D / Apolo S | Vmi Tecnologias Ltda | 2020-12-01 | 102 | 0 |
| K201825 | MiniCAT 2D | Xoran Technologies, LLC | 2020-11-20 | 141 | 0 |
| K201670 | YSIO X.pree | Siemens Medical Solutions USA, Inc. | 2020-10-21 | 124 | 0 |
| K202293 | Radiographic System Challenge X | Sedecal., Sa. | 2020-10-07 | 55 | 0 |
| K202572 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2020-09-24 | 20 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda