Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OWB — Predicate Candidate Screening
323 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
243 days90th percentile
323clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2026-08-07 | 221 | 0 |
| K260607 | Shield System (Siemens 30x40) | Radiaction , Ltd. | 2026-07-31 | 157 | 0 |
| K253670 | SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. | 2026-07-10 | 231 | 0 |
| K252735 | C-beam | Pulmera, Inc. | 2026-05-22 | 267 | 0 |
| K252503 | Intelligent NR | Canon, Inc. | 2026-04-30 | 265 | 0 |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; | Siemens Medical Solutions USA, Inc. | 2026-04-24 | 122 | 0 |
| K253752 | ARTIS genio floor; ARTIS icono.explore floor | Siemens Medical Solutions USA, Inc. | 2026-04-23 | 149 | 0 |
| K252229 | BELLIGER ACE | Genoray Co., Ltd. | 2026-04-02 | 260 | 0 |
| K252099 | Trinias | Shimadzu Corporation | 2026-03-24 | 264 | 0 |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imag | Canon Medical Systems Corporation | 2026-03-10 | 113 | 0 |
| K252500 | CARA System | Cara Medical, Ltd. | 2026-02-20 | 196 | 0 |
| K251992 | ArmSure Fluoroscopic Positioning System | Savfe Co. , Ltd. | 2026-02-11 | 229 | 0 |
| K254186 | Azurion R3.1 | Philips Medical Systems B.V. | 2026-01-16 | 24 | 0 |
| K252068 | MC2 Portable X-ray System | Oxos Medical | 2025-12-22 | 174 | 1 |
| K251893 | SKAN C PULSAR | Skanray Technologies Limited | 2025-12-16 | 179 | 0 |
| K251199 | Allia Moveo | GE Medical Systems SCS | 2025-12-09 | 235 | 1 |
| K250241 | Cios Select | Siemens Medical Solutions USA, Inc. | 2025-11-04 | 281 | 0 |
| K251827 | Azurion R3.1 | Philips Medical Systems B.V. | 2025-10-24 | 133 | 0 |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imag | Canon Medical Systems Corporation | 2025-10-10 | 136 | 0 |
| K251523 | Cios Spin | Siemens Medical Solutions USA, Inc. | 2025-07-29 | 74 | 0 |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PA | Brainlab AG | 2025-07-22 | 259 | 0 |
| K250660 | LUMINOS Q.namix T; LUMINOS Q.namix R | Siemens Medical Solutions | 2025-07-14 | 131 | 2 |
| K251520 | Cios Alpha; Cios Flow | Siemens Medical Solutions USA, Inc. | 2025-07-09 | 54 | 0 |
| K243884 | TAVIPILOT | Caranx Medical | 2025-07-07 | 201 | 0 |
| K250010 | EXTRON 3; EXTRON 5; EXTRON 7 | DRTECH Corporation | 2025-06-10 | 159 | 0 |
| K243411 | Diagnostic X-ray System | Nanjing Perlove Medical Equipment Co., Ltd. | 2025-05-19 | 199 | 0 |
| K242731 | MasteRad MiniX Mobile Digital Imaging System (Mini-X) | Medicatech USA, Inc. | 2025-05-16 | 248 | 0 |
| K250282 | Persona C HR | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2025-04-30 | 89 | 0 |
| K243376 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | 2025-04-28 | 180 | 0 |
| K234067 | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mo | Medphoton GmbH | 2025-03-28 | 462 | 0 |
| K243646 | Ziehm Solo FD | Ziehm Imaging GmbH | 2025-03-17 | 111 | 0 |
| K243735 | Ziehm Vision FD | Ziehm Imaging GmbH | 2025-03-13 | 99 | 0 |
| K243446 | 3DXR | GE Medical Systems SCS | 2025-02-25 | 111 | 0 |
| K243303 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2025-01-21 | 92 | 0 |
| K243328 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2025-01-15 | 83 | 0 |
| K241567 | MC2 Portable X-ray System | Oxos Medical | 2024-12-06 | 189 | 0 |
| K241572 | ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); | Siemens Medical Solutions USA, Inc. | 2024-10-22 | 144 | 11 |
| K233107 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 | Canon Medical Systems Corporation | 2024-08-30 | 338 | 2 |
| K240465 | O-arm O2 Imaging System | Medtronic Navigation, Inc. | 2024-06-21 | 126 | 2 |
| K233230 | See Factor CT3™ | Epica International, Inc. | 2024-06-21 | 267 | 0 |
| K240224 | Zenition 90 | Philips Medical Systems Nederlands B.V. | 2024-05-22 | 117 | 0 |
| K240199 | IntraOp Alignment System | Alphatec Spine, Inc. | 2024-05-22 | 118 | 0 |
| K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | Canon, Inc. | 2024-04-26 | 269 | 0 |
| K233748 | CIARTIC Move (VB10) | Siemens Medical Solutions USA, Inc. | 2024-03-15 | 114 | 0 |
| K232420 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2024-02-16 | 189 | 0 |
| K240099 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2024-02-05 | 24 | 1 |
| K240020 | Ziehm Vision FD | Ziehm Imaging GmbH | 2024-01-30 | 28 | 1 |
| K234109 | Ziehm Solo FD | Ziehm Imaging GmbH | 2024-01-26 | 30 | 1 |
| K230949 | ARTIS pheno (VE30A) | Siemens Medical Solutions USA, Inc. | 2023-12-15 | 255 | 2 |
| K231700 | Ziehm Vision FD | Ziehm Imaging GmbH | 2023-12-15 | 186 | 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