OWB
323 FDA 510(k) clearances · Product code
89 daysmedian time to decision
243 days90th percentile
323clearances measured
FDA profile
- Official device name
- Interventional Fluoroscopic X-Ray System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1650
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
- FDA definition
- Interventional fluoroscopy
- Adverse events (MAUDE)
- 2021: 1,981 · 2022: 2,932 · 2023: 7,604 · 2024: 7,942 · 2025: 14,140 · 2026: 2,849
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Zenition 30 (K254205) | Philips Medical Systems Nederland B.V. | 2026-08-07 |
| Shield System (Siemens 30x40) (K260607) | Radiaction , Ltd. | 2026-07-31 |
| SmartCT (R3.0 (L10)) (K253670) | Philips Medical Systems B.V. | 2026-07-10 |
| C-beam (K252735) | Pulmera, Inc. | 2026-05-22 |
| Intelligent NR (K252503) | Canon, Inc. | 2026-04-30 |
| ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (K254173) | Siemens Medical Solutions USA, Inc. | 2026-04-24 |
| ARTIS genio floor; ARTIS icono.explore floor (K253752) | Siemens Medical Solutions USA, Inc. | 2026-04-23 |
| BELLIGER ACE (K252229) | Genoray Co., Ltd. | 2026-04-02 |
| Trinias (K252099) | Shimadzu Corporation | 2026-03-24 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (K253584) | Canon Medical Systems Corporation | 2026-03-10 |
| CARA System (K252500) | Cara Medical, Ltd. | 2026-02-20 |
| ArmSure Fluoroscopic Positioning System (K251992) | Savfe Co. , Ltd. | 2026-02-11 |
| Azurion R3.1 (K254186) | Philips Medical Systems B.V. | 2026-01-16 |
| MC2 Portable X-ray System (K252068) | Oxos Medical | 2025-12-22 |
| SKAN C PULSAR (K251893) | Skanray Technologies Limited | 2025-12-16 |
| Allia Moveo (K251199) | GE Medical Systems SCS | 2025-12-09 |
| Cios Select (K250241) | Siemens Medical Solutions USA, Inc. | 2025-11-04 |
| Azurion R3.1 (K251827) | Philips Medical Systems B.V. | 2025-10-24 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (K251602) | Canon Medical Systems Corporation | 2025-10-10 |
| Cios Spin (K251523) | Siemens Medical Solutions USA, Inc. | 2025-07-29 |
| Vascular Navigation PAD 2.0; Navigation Software Vascular PAD (K243432) | Brainlab AG | 2025-07-22 |
| LUMINOS Q.namix T; LUMINOS Q.namix R (K250660) | Siemens Medical Solutions | 2025-07-14 |
| Cios Alpha; Cios Flow (K251520) | Siemens Medical Solutions USA, Inc. | 2025-07-09 |
| TAVIPILOT (K243884) | Caranx Medical | 2025-07-07 |
| EXTRON 3; EXTRON 5; EXTRON 7 (K250010) | DRTECH Corporation | 2025-06-10 |
| Diagnostic X-ray System (K243411) | Nanjing Perlove Medical Equipment Co., Ltd. | 2025-05-19 |
| MasteRad MiniX Mobile Digital Imaging System (Mini-X) (K242731) | Medicatech USA, Inc. | 2025-05-16 |
| Persona C HR (K250282) | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2025-04-30 |
| uAngio AVIVA CX (K243376) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-04-28 |
| ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) (K234067) | Medphoton GmbH | 2025-03-28 |
| Ziehm Solo FD (K243646) | Ziehm Imaging GmbH | 2025-03-17 |
| Ziehm Vision FD (K243735) | Ziehm Imaging GmbH | 2025-03-13 |
| 3DXR (K243446) | GE Medical Systems SCS | 2025-02-25 |
| Ziehm Vision RFD 3D (K243303) | Ziehm Imaging GmbH | 2025-01-21 |
| Ziehm Vision RFD (K243328) | Ziehm Imaging GmbH | 2025-01-15 |
| MC2 Portable X-ray System (K241567) | Oxos Medical | 2024-12-06 |
| ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) (K241572) | Siemens Medical Solutions USA, Inc. | 2024-10-22 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 (K233107) | Canon Medical Systems Corporation | 2024-08-30 |
| O-arm O2 Imaging System (K240465) | Medtronic Navigation, Inc. | 2024-06-21 |
| See Factor CT3™ (K233230) | Epica International, Inc. | 2024-06-21 |
| Zenition 90 (K240224) | Philips Medical Systems Nederlands B.V. | 2024-05-22 |
| IntraOp Alignment System (K240199) | Alphatec Spine, Inc. | 2024-05-22 |
| DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl (K232298) | Canon, Inc. | 2024-04-26 |
| CIARTIC Move (VB10) (K233748) | Siemens Medical Solutions USA, Inc. | 2024-03-15 |
| Zenition 30 (K232420) | Philips Medical Systems Nederland B.V. | 2024-02-16 |
| Ziehm Vision RFD (K240099) | Ziehm Imaging GmbH | 2024-02-05 |
| Ziehm Vision FD (K240020) | Ziehm Imaging GmbH | 2024-01-30 |
| Ziehm Solo FD (K234109) | Ziehm Imaging GmbH | 2024-01-26 |
| ARTIS pheno (VE30A) (K230949) | Siemens Medical Solutions USA, Inc. | 2023-12-15 |
| Ziehm Vision FD (K231700) | Ziehm Imaging GmbH | 2023-12-15 |
| ARTIS icono (VE30A) (K230950) | Siemens Medical Solutions USA, Inc. | 2023-12-14 |
| Ziehm Solo FD (K231669) | Ziehm Imaging GmbH | 2023-12-12 |
| Ziehm Vision RFD (K231692) | Ziehm Imaging GmbH | 2023-11-20 |
| XPLUS 35 Series (XPLUS 35, XPLUS 35FD) (K233200) | GEMSS HEALTHCARE CO., LTD. | 2023-11-16 |
| Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR (K232344) | GE Medical Systems SCS | 2023-10-11 |
| EXTRON 5; EXTRON 7 (K230871) | DRTECH Corporation | 2023-08-17 |
| Oscar 15 & Oscar 15i (K230787) | Genoray Co., Ltd. | 2023-07-20 |
| Ziehm Vision RFD 3D (K231701) | Ziehm Imaging GmbH | 2023-07-10 |
| F3 (K222998) | Acrew Imaging, Inc. | 2023-06-20 |
| ANT-X System (K230185) | Ndr Medical Technology Pte. , Ltd. | 2023-06-01 |
| nView s1 with nav option (K221344) | Nview Medical | 2022-12-28 |
| Cios Select (VA21) Flat Panel (K223410) | Siemens Medical Solutions USA, Inc. | 2022-12-07 |
| Cios Select (VA21) Image Intensifier (K223409) | Siemens Medical Solutions USA, Inc. | 2022-12-06 |
| Bolt Navigation System (K213768) | Circinus Medical Technology, LLC | 2022-12-01 |
| Multitom Rax (K221281) | Siemens Medical Solutions | 2022-11-17 |
| EndoNaut (K222070) | Therenva Sas | 2022-10-25 |
| Garion Image-Intensified Fluoroscopic X-Ray System, Mobile (K222080) | Sg Healthcare Co, Ltd. | 2022-10-06 |
| Shield System (K222625) | Radiaction , Ltd. | 2022-09-30 |
| XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 (K220342) | Canon Medical Systems Corporation | 2022-09-27 |
| TRON (K221230) | Xoran Technologies, LLC | 2022-07-28 |
| Trinias (K221922) | Shimadzu Corporation Medical Systems Division | 2022-07-28 |
| ARTIS icono (Ceiling Configuration) (K221516) | Siemens Medical Solutions USA, Inc. | 2022-07-19 |
| ARTIS pheno (VE21) System (K220409) | Siemens Medical Solutions USA, Inc. | 2022-06-29 |
| ARTIS icono (VE21) System (K220432) | Siemens Medical Solutions USA, Inc. | 2022-06-29 |
| D²RS and D²RS 9090 (K221335) | Stephanix | 2022-06-07 |
| Cardiovascular Angiography System (K220311) | Allengers Medical Systems Limited | 2022-05-03 |
| SURGIVISIO Device (K220946) | Ecential Robotics | 2022-04-15 |
| Shield System (K212159) | Radiaction , Ltd. | 2022-03-30 |
| SURGIVISIO Device (K220627) | Ecential Robotics | 2022-03-18 |
| ZEN-2090 Turbo (K211780) | Genoray Co., Ltd. | 2022-03-09 |
| Multitom Rax with True2scale Body Scan Option (K212212) | Siemens Medical Solutions | 2022-02-18 |
| D²RS and D²RS 9090 (K213479) | Stephanix | 2021-12-23 |
| Cydar EV (Series B) and Cydar EV Maps (K212442) | Cydar , Ltd. | 2021-12-03 |
| ControlRad Select Model Z (K213455) | Controlrad, Inc. | 2021-11-24 |
| Soteria.AI (K212336) | Omega Medical Imaging, LLC | 2021-11-17 |
| FDR Cross (DR-XD 3000) (K212956) | Fujifilm Corporation | 2021-11-08 |
| VFSS Pro Mobile Digital Imaging System (K212523) | Imagexray, LLC | 2021-11-05 |
| nView s1 with nav option (K211064) | Nview Medical | 2021-10-29 |
| Zenition 70 (K212813) | Philips Medical Systems Nederland B.V. | 2021-10-01 |
| Virtual C DRF-NEO Digital Imaging System (K212557) | Portavision Medical, LLC | 2021-09-24 |
| EndoNaut (K212383) | Therenva Sas | 2021-08-31 |
| ARCO FP-S (K211777) | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2021-08-13 |
| Excelsius3D (K210912) | Globus Medical, Inc. | 2021-08-12 |
| ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 (K211782) | Controlrad, Inc. | 2021-07-01 |
| Virtual C DRF Digital Imaging System (K211191) | Portavision Medical, LLC | 2021-06-24 |
| Trinias (K203535) | Shimadzu Corporation Medical Systems | 2021-04-28 |
| Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 (K210900) | Canon Medical Systems Corporation | 2021-04-12 |
| StentBoost Mobile (K203623) | Philips India Limited | 2021-04-05 |
| Surgivisio system (K202547) | Surgivisio | 2021-03-26 |
| Cios Select (VA21) Flat Panel (K210309) | Siemens Medical Solutions USA, Inc. | 2021-03-05 |
Track OWB automatically
Every clearance here is in the API, with alerts when new ones post.