Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LLZ · Predicate Candidate Screening
2,283 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
239 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 | 133 | 0 |
| K260588 | Cleerly LABS | Cleerly, Inc. | 2026-07-29 | 159 | 0 |
| K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026-07-24 | 7 | 0 |
| K262143 | ImageGrid StreamVue | Candelis, Inc. | 2026-07-23 | 28 | 0 |
| K260500 | ResolutionMD | ResolutionMD, Inc. | 2026-07-21 | 158 | 0 |
| K262120 | Avara Viewer | Avara Software | 2026-07-10 | 17 | 0 |
| K253899 | 3D-Anywhere | Provect.AI | 2026-07-09 | 216 | 0 |
| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | 2026-07-06 | 63 | 0 |
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026-06-30 | 130 | 0 |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | 2026-06-25 | 150 | 0 |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | 2026-06-22 | 264 | 0 |
| K261352 | 2D Hip Planning Software | One Ortho | 2026-06-08 | 45 | 0 |
| K260116 | CustoMED Viewer | CustoMED , Ltd. | 2026-06-03 | 140 | 0 |
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 | 148 | 0 |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and C | Cercare Medical A/S | 2026-05-18 | 168 | 0 |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026-05-14 | 150 | 0 |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | 2026-05-08 | 98 | 0 |
| K260716 | Neowise | Cefla S.C. | 2026-05-04 | 60 | 0 |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | 2026-04-24 | 112 | 0 |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | 2026-04-23 | 115 | 0 |
| K253029 | RW-1 | Mediott, Inc. | 2026-03-31 | 193 | 0 |
| K253950 | Avatar Medical Vision | Avatar Medical | 2026-03-30 | 110 | 0 |
| K252195 | ARTICOR planner | Artiness S.R.L | 2026-03-27 | 256 | 0 |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026-03-13 | 170 | 0 |
| K260479 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026-03-13 | 28 | 1 |
| K251964 | Mimics Thoracic Planner | Materialise NV | 2026-03-12 | 259 | 0 |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026-02-23 | 129 | 0 |
| K260205 | AS Software Version Asera | AS Software, LLC | 2026-02-19 | 27 | 0 |
| K251577 | LAIA XR | Augmented Reality Software S.L. | 2026-02-06 | 260 | 0 |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | 2026-02-06 | 60 | 0 |
| K253639 | View | GE Healthcare | 2026-01-08 | 50 | 0 |
| K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. | 2026-01-08 | 43 | 0 |
| K253008 | maiLink | Maihub Corp. | 2026-01-05 | 108 | 0 |
| K251883 | MIM – LesionID Pro | Mim Software, Inc. | 2025-12-11 | 174 | 0 |
| K251880 | Archy Dental Imaging | Archy Dental, Inc. | 2025-11-21 | 156 | 0 |
| K253495 | syngo.MR Applications (VB80) | Siemens Healthineers AG | 2025-11-20 | 23 | 0 |
| K251410 | VXvue | Vieworks Co., Ltd. | 2025-11-04 | 181 | 0 |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2025-11-03 | 168 | 0 |
| K252547 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2025-10-28 | 77 | 1 |
| K251030 | Sirona Advanced Imaging Suite | Sirona Medical | 2025-10-22 | 202 | 0 |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart L | Brainlab AG | 2025-10-16 | 70 | 0 |
| K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025-10-15 | 93 | 0 |
| K251363 | ProKnow DS | Elekta Solutions AB | 2025-10-08 | 160 | 0 |
| K250039 | HPACS | Healthhub | 2025-10-03 | 268 | 0 |
| K251215 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nederland B.V. | 2025-10-02 | 167 | 0 |
| K250045 | uWS-Angio Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-24 | 257 | 0 |
| K250040 | uWS-Angio | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-12 | 247 | 0 |
| K242314 | Minimally Invasive Prostate Surgery Navigation System(Model: | Augment Intelligent Medical System (China) Co., Ltd. | 2025-09-11 | 402 | 0 |
| K252608 | AI-Rad Companion Prostate MR | Siemens Healthcare GmbH | 2025-09-09 | 22 | 0 |
| K251168 | Image Suite | Carestream Health, Inc. | 2025-09-04 | 142 | 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