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 |
|---|---|---|---|
| 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 |
| K243376 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | 2025-04-28 |
| K234067 | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) | Medphoton GmbH | 2025-03-28 |
| K243646 | Ziehm Solo FD | Ziehm Imaging GmbH | 2025-03-17 |
| K243735 | Ziehm Vision FD | Ziehm Imaging GmbH | 2025-03-13 |
| K243446 | 3DXR | GE Medical Systems SCS | 2025-02-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060508110057 | Cydar Maps | CYDAR LIMITED | 2026-05-27 |
| 08055186671256 | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2026-05-21 |
| 08055186671249 | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2026-05-21 |
| 08055186671232 | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2026-05-21 |
| 08055186671225 | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2026-05-21 |
| 08809365283033 | SG Healthcare | SG Healthcare Co., Ltd. | 2026-04-24 |
| 08809244060557 | Genoray | GENORAY CO., LTD. | 2026-04-10 |
| 08809244060632 | Genoray | GENORAY CO., LTD. | 2026-04-10 |
| 08809244060533 | Genoray | GENORAY CO., LTD. | 2026-04-10 |
| 08809244060601 | Genoray | GENORAY CO., LTD. | 2025-12-01 |
| 08800018422601 | EXTRON 3 | DRTECH Corporation | 2025-06-17 |
| 08809244060465 | Genoray | GENORAY CO., LTD. | 2025-05-02 |
| 07613327664089 | Philips Healthcare | STRYKER SUSTAINABILITY SOLUTIONS, INC. | 2025-02-11 |
| 08053307591070 | TRIDENT | TECHNIX SPA | 2024-11-06 |
| 08053307591087 | TRIDENT | TECHNIX SPA | 2024-11-06 |
| 08809244060458 | Genoray | GENORAY CO., LTD. | 2023-11-17 |
| 08809244060069 | Genoray | GENORAY CO., LTD. | 2023-07-28 |
| 08809244061219 | Genoray | GENORAY CO., LTD. | 2018-04-11 |
| 08800019200253 | NA | ECOTRON | 2018-03-29 |
| 08800019200277 | NA | ECOTRON | 2018-03-29 |
| 08800019200260 | NA | ECOTRON | 2018-03-29 |
| 08809246620049 | Interventional Fluoroscopic Mobile X-ray System | GEMSS MEDICAL SYSTEMS CO.,LTD. | 2018-02-05 |
| EZIEZIEHMSOLOFD1 | Ziehm Solo FD | Ziehm Imaging GmbH | 2016-11-17 |
| 08800019200093 | NA | ECOTRON | 2016-11-05 |
| 08809244060083 | Genoray | GENORAY CO., LTD. | 2016-09-24 |
| 08809246620001 | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED | GEMSS MEDICAL SYSTEMS CO.,LTD. | 2016-09-24 |
| EZIEZIEHMVISIONRFD3D1 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2016-09-23 |
| EZIEZIEHMVISIONRFD1 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2016-09-23 |
| EZIEZIEHMVISIONR1 | Ziehm Vision R | Ziehm Imaging GmbH | 2016-09-23 |
| EZIEZIEHMSOLO1 | Ziehm Solo | Ziehm Imaging GmbH | 2016-09-23 |