Product code OWB
- Device name
- Interventional Fluoroscopic X-Ray System
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1650
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Interventional fluoroscopy
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253726 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | 2026-08-21 |
| K261413 | EXTRON 3;EXTRON 6 | DRTECH Corporation | 2026-08-19 |
| K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2026-08-07 |
| K260607 | Shield System (Siemens 30x40) | Radiaction , Ltd. | 2026-07-31 |
| K253670 | SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. | 2026-07-10 |
| K252735 | C-beam | Pulmera, Inc. | 2026-05-22 |
| K252503 | Intelligent NR | Canon, Inc. | 2026-04-30 |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | Siemens Medical Solutions USA, Inc. | 2026-04-24 |
| K253752 | ARTIS genio floor; ARTIS icono.explore floor | Siemens Medical Solutions USA, Inc. | 2026-04-23 |
| K252229 | BELLIGER ACE | Genoray Co., Ltd. | 2026-04-02 |
| K252099 | Trinias | Shimadzu Corporation | 2026-03-24 |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation | 2026-03-10 |
| K252500 | CARA System | Cara Medical, Ltd. | 2026-02-20 |
| K251992 | ArmSure Fluoroscopic Positioning System | Savfe Co. , Ltd. | 2026-02-11 |
| K254186 | Azurion R3.1 | Philips Medical Systems B.V. | 2026-01-16 |
| K252068 | MC2 Portable X-ray System | Oxos Medical | 2025-12-22 |
| K251893 | SKAN C PULSAR | Skanray Technologies Limited | 2025-12-16 |
| K251199 | Allia Moveo | GE Medical Systems SCS | 2025-12-09 |
| K250241 | Cios Select | Siemens Medical Solutions USA, Inc. | 2025-11-04 |
| K251827 | Azurion R3.1 | Philips Medical Systems B.V. | 2025-10-24 |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Canon Medical Systems Corporation | 2025-10-10 |
| K251523 | Cios Spin | Siemens Medical Solutions USA, Inc. | 2025-07-29 |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | Brainlab AG | 2025-07-22 |
| K250660 | LUMINOS Q.namix T; LUMINOS Q.namix R | Siemens Medical Solutions | 2025-07-14 |
| K251520 | Cios Alpha; Cios Flow | Siemens Medical Solutions USA, Inc. | 2025-07-09 |
| K243884 | TAVIPILOT | Caranx Medical | 2025-07-07 |
| K250010 | EXTRON 3; EXTRON 5; EXTRON 7 | DRTECH Corporation | 2025-06-10 |
| K243411 | Diagnostic X-ray System | Nanjing Perlove Medical Equipment Co., Ltd. | 2025-05-19 |
| K242731 | MasteRad MiniX Mobile Digital Imaging System (Mini-X) | Medicatech USA, Inc. | 2025-05-16 |
| K250282 | Persona C HR | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2025-04-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03701311500940 | 3D Imaging Set SPX1 | ECENTIAL ROBOTICS | 2023-09-06 |
| 03701311501121 | SURGIVISIO DEVICE | ECENTIAL ROBOTICS | 2023-09-04 |
| 03701311500971 | 3D Offset Imaging Set SPX1 | ECENTIAL ROBOTICS | 2023-09-04 |
| 03701311500407 | SURGIVISIO | ECENTIAL ROBOTICS | 2023-03-01 |
| 03701311500391 | 3D Offset Imaging Set SPX1 | ECENTIAL ROBOTICS | 2023-03-01 |
| 03701311500018 | 3D Imaging Set SPX1 | ECENTIAL ROBOTICS | 2023-03-01 |
| 00884838103450 | StentBoost Mobile | Philips India Limited | 2021-06-15 |
| 00884838085732 | SmartCT | Philips Medical Systems Nederland B.V. | 2021-02-25 |
| 00884838101890 | StentBoost Live | Philips Medical Systems Nederland B.V. | 2020-11-10 |
| 00884838101883 | Dynamic Coronary Roadmap | Philips Medical Systems Nederland B.V. | 2020-11-10 |
| 00884838088566 | SmartPerfusion | Philips Medical Systems Nederland B.V. | 2018-11-19 |
| 00884838086777 | Dynamic Coronary Roadmap | Philips Medical Systems Nederland B.V. | 2017-11-07 |
| 00884838080805 | Dynamic Coronary Roadmap | Philips Medical Systems Nederland B.V. | 2017-06-29 |
| 00884838080812 | StentBoost Live | Philips Medical Systems Nederland B.V. | 2017-06-29 |
| 00884838084766 | 3D-RA | Philips Medical Systems Nederland B.V. | 2017-03-28 |
| 00884838064768 | AneurysmFlow | Philips Medical Systems Nederland B.V. | 2017-03-03 |
| 00884838075863 | 2D Quantitative Analysis | Philips Medical Systems Nederland B.V. | 2017-02-20 |
| 00884838064782 | CT Trueview | Philips Medical Systems Nederland B.V. | 2017-01-19 |
| 00884838080744 | HeartNavigator | Philips Medical Systems Nederland B.V. | 2016-11-30 |
| 00884838059184 | EP navigator | Philips Medical Systems Nederland B.V. | 2016-09-24 |
| 00884838064775 | VesselNavigator | Philips Medical Systems Nederland B.V. | 2016-09-24 |
| 00884838059306 | XperCT Dual | Philips Medical Systems Nederland B.V. | 2016-09-24 |
| 00884838059290 | EmboGuide | Philips Medical Systems Nederland B.V. | 2016-09-24 |
| 00884838059276 | 2D Perfusion | Philips Medical Systems Nederland B.V. | 2016-09-24 |
| 00884838059269 | StentBoost | Philips Medical Systems Nederland B.V. | 2016-09-24 |
| 00884838059252 | XperGuide | Philips Medical Systems Nederland B.V. | 2016-09-24 |
| 00884838059238 | MR-CT Roadmap | Philips Medical Systems Nederland B.V. | 2016-09-24 |
| 00884838059221 | 3D Roadmap | Philips Medical Systems Nederland B.V. | 2016-09-24 |
| 00884838059207 | HeartNavigator | Philips Medical Systems Nederland B.V. | 2016-09-24 |
| 00884838059191 | Interventional Workspot | Philips Medical Systems Nederland B.V. | 2016-09-24 |