Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Radiology — Predicate Candidate Screening
14,649 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
133 daysmedian FDA review time
265 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252571 | mdprostate | Mediaire GmbH | 2026-08-07 | 358 | 0 |
| K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2026-08-07 | 221 | 0 |
| K261668 | Venue Go | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | 2026-08-07 | 79 | 0 |
| K261059 | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | 2026-08-06 | 128 | 0 |
| K253902 | RealGUIDE | 3DIEMME SRL | 2026-08-04 | 242 | 0 |
| K262311 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026-08-04 | 27 | 0 |
| K261856 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | 2026-08-03 | 60 | 0 |
| K260236 | XLITE | GEMSS HEALTHCARE CO., LTD. | 2026-08-03 | 189 | 0 |
| K261331 | I-Genius (100019400) | Esaote, S.p.A. | 2026-07-31 | 100 | 0 |
| K253800 | 0909FCE, 0909FCE-HS | Rayence Co., Ltd. | 2026-07-31 | 245 | 0 |
| K253835 | Affinity | Hermes Medical Solutions AB | 2026-07-31 | 242 | 0 |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAG | Siemens Healthineers AG | 2026-07-31 | 137 | 0 |
| K260607 | Shield System (Siemens 30x40) | Radiaction , Ltd. | 2026-07-31 | 157 | 0 |
| K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 | 133 | 0 |
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Br | Philips Medical Systems Nederland B.V. | 2026-07-30 | 21 | 0 |
| K260980 | cmAngio® V2.0 | Curemetrix, Inc. | 2026-07-30 | 127 | 0 |
| K260161 | SmartGuide Disposable Guides and Grids | UC-CARE , Ltd. | 2026-07-30 | 191 | 0 |
| K261835 | LOGIQ Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-07-30 | 58 | 0 |
| K261288 | Handheld Ultrasound Scanner | IMGFAX CO., LTD. | 2026-07-30 | 101 | 0 |
| K261210 | Cleerly Plaque | Cleerly, Inc. | 2026-07-29 | 106 | 0 |
| K260588 | Cleerly LABS | Cleerly, Inc. | 2026-07-29 | 159 | 0 |
| K253450 | BodyTom Elite (NL4000) | NeuroLogica Corp., a Samsung Company | 2026-07-28 | 299 | 0 |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diag | Samsung Medison Co., Ltd. | 2026-07-28 | 89 | 0 |
| K261427 | uMI Panvivo (uMI Panvivo M) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-07-28 | 89 | 0 |
| K260303 | See-Mode Augmented Reporting Tool, Breast (SMART-B) | See-Mode Technologies Pty, Ltd. | 2026-07-28 | 179 | 0 |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Af | Philips Ultrasound, LLC | 2026-07-27 | 104 | 0 |
| K262474 | ND Needle Guidance System | Accurate Access, LLC | 2026-07-27 | 10 | 0 |
| K260192 | DIANA | ROPCA ApS | 2026-07-24 | 183 | 0 |
| K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026-07-24 | 7 | 0 |
| K262383 | LumenCare Azure | Nucletron B.V. | 2026-07-24 | 11 | 0 |
| K261014 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2026-07-24 | 119 | 0 |
| K253452 | Accuro 3S | Rivanna Medical, Inc. | 2026-07-24 | 291 | 0 |
| K261349 | SwiftMR | Airs Medical, Inc. | 2026-07-24 | 91 | 0 |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/ | Philips Medical Systems Nederland B.V. | 2026-07-24 | 17 | 0 |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpr | Beijing Konted Medical Technology Co.,Ltd | 2026-07-23 | 113 | 0 |
| K262143 | ImageGrid StreamVue | Candelis, Inc. | 2026-07-23 | 28 | 0 |
| K254096 | VELMENI for DENTISTS (V4D) 3D | Velmeni, Inc. | 2026-07-23 | 216 | 0 |
| K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series) | Hefei Meyer Optoelectronic Technology, Inc. | 2026-07-23 | 56 | 0 |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ | Esonic Technology (Wuhan) Co., Ltd. | 2026-07-23 | 97 | 0 |
| K260500 | ResolutionMD | ResolutionMD, Inc. | 2026-07-21 | 158 | 0 |
| K253770 | CardIQ Suite | GE Medical Systems SCS | 2026-07-21 | 237 | 0 |
| K261535 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | 2026-07-20 | 73 | 0 |
| K260694 | ZEISS CLINIC 360 | Carl Zeiss Meditec, AG | 2026-07-17 | 136 | 0 |
| K253963 | Cubresa BrainPET | Cubresa, Inc. | 2026-07-17 | 218 | 0 |
| K260338 | ThinkSono Guidance | ThinkSono GmbH | 2026-07-15 | 163 | 0 |
| K260206 | SkeletonPlanner | UPlanner B.V. - Presurgeo | 2026-07-15 | 173 | 0 |
| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp. | 2026-07-15 | 121 | 0 |
| K261085 | Rapid Vessel Occlusion (Rapid VO) | iSchemaview | 2026-07-13 | 103 | 0 |
| K262120 | Avara Viewer | Avara Software | 2026-07-10 | 17 | 0 |
| K253670 | SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. | 2026-07-10 | 231 | 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