Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QIH — Predicate Candidate Screening
319 FDA 510(k) clearances under this product code; the 50 most recent screened below.
140 daysmedian FDA review time
265 days90th percentile
319clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252571 | mdprostate | Mediaire GmbH | 2026-08-07 | 358 | 0 |
| K253902 | RealGUIDE | 3DIEMME SRL | 2026-08-04 | 242 | 0 |
| K253835 | Affinity | Hermes Medical Solutions AB | 2026-07-31 | 242 | 0 |
| K260980 | cmAngio® V2.0 | Curemetrix, Inc. | 2026-07-30 | 127 | 0 |
| K261210 | Cleerly Plaque | Cleerly, Inc. | 2026-07-29 | 106 | 0 |
| K260192 | DIANA | ROPCA ApS | 2026-07-24 | 183 | 0 |
| K261349 | SwiftMR | Airs Medical, Inc. | 2026-07-24 | 91 | 0 |
| K254096 | VELMENI for DENTISTS (V4D) 3D | Velmeni, Inc. | 2026-07-23 | 216 | 0 |
| K261535 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | 2026-07-20 | 73 | 0 |
| K260206 | SkeletonPlanner | UPlanner B.V. - Presurgeo | 2026-07-15 | 173 | 0 |
| K260973 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026-07-07 | 105 | 0 |
| K253628 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | 2026-06-29 | 222 | 0 |
| K253969 | ADAS 3D | Adas3D Medical S.L. | 2026-06-29 | 200 | 0 |
| K253786 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | 2026-06-25 | 211 | 0 |
| K260316 | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S | 2026-06-22 | 143 | 0 |
| K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | 2026-06-18 | 27 | 0 |
| K253690 | LungMaps | Siemens Healthineers AG | 2026-06-15 | 206 | 0 |
| K253172 | MediAI-OA | Crescom Co., Ltd. | 2026-06-15 | 262 | 0 |
| K260300 | WatchMate Software | Anumana, Inc. | 2026-06-15 | 136 | 0 |
| K260406 | Brainomix 360 Hyperdensity | Brainomix Limited | 2026-06-12 | 123 | 0 |
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2026-06-11 | 132 | 0 |
| K260497 | DEEPVESSEL Plaque | Keya Medical Technology Co., Ltd. | 2026-06-04 | 111 | 0 |
| K260077 | OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. | 2026-05-29 | 137 | 0 |
| K261405 | ANDI 2.2 | Imeka Solutions, Inc. | 2026-05-28 | 29 | 0 |
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Plan | Canon Medical Informatics, Inc. | 2026-05-22 | 112 | 0 |
| K254131 | BAC | DeepHealth, Inc. | 2026-05-21 | 150 | 0 |
| K260234 | MSK Go | Smart Alfa Teknoloji San. Ve Tic. A.S. | 2026-05-21 | 115 | 0 |
| K254120 | SubtleHD-CT (1.x) | Subtle Medical, Inc. | 2026-05-15 | 147 | 0 |
| K252563 | Neurophet SCALE PET | Neurophet., Inc. | 2026-05-15 | 274 | 0 |
| K261289 | UNiD™ Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | 2026-05-15 | 25 | 0 |
| K261273 | Neurophet AQUA | Neurophet., Inc. | 2026-05-15 | 28 | 0 |
| K260032 | Morph | BeauBrain Healthcare, Inc. | 2026-05-13 | 127 | 0 |
| K254189 | Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | 2026-04-30 | 128 | 0 |
| K254184 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2026-04-29 | 127 | 0 |
| K260785 | DS Core CBCT Anatomy | Dentsply Sirona | 2026-04-23 | 44 | 0 |
| K253077 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-22 | 211 | 0 |
| K252332 | Folliscan | Mim Fertility | 2026-04-20 | 269 | 0 |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorit | Ge Medical Systems, LLC | 2026-04-14 | 166 | 0 |
| K252708 | Relu Cloud | Relu BV | 2026-04-10 | 226 | 0 |
| K253930 | Overjet Iris Intelligent Imaging System | Overjet, Inc. | 2026-04-10 | 122 | 0 |
| K253689 | syngo Dynamics (VA41F) | Siemens Healthcare GmbH | 2026-04-10 | 140 | 0 |
| K254015 | CoLumbo C-Spine | Smart Soft Healthcare AD | 2026-04-01 | 107 | 0 |
| K254207 | AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. | 2026-03-30 | 91 | 0 |
| K253775 | SwiftMR | Airs Medical, Inc. | 2026-03-26 | 120 | 0 |
| K253614 | EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. | 2026-03-17 | 119 | 0 |
| K253944 | Data Analysis Facilitation Suite (DAFS) | Voronoi Health Analytics Incorporated | 2026-03-16 | 96 | 0 |
| K252261 | InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026-03-13 | 235 | 0 |
| K253551 | VELYS™ Hip Navigation | Depuy Ireland UC | 2026-03-06 | 112 | 0 |
| K252538 | CEPHX3D | Orca Dental AI , Ltd. | 2026-03-05 | 205 | 0 |
| K253593 | Clarius Ejection Fraction AI | Clarius Mobile Health Corp. | 2026-03-02 | 105 | 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