FDA Product Code
FDA Product Code OWB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1650
510(k) Clearances — 325 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253726 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | 2026-08-21 | Traditional | PDF ↗ |
| K261413 | EXTRON 3;EXTRON 6 | DRTECH Corporation | 2026-08-19 | Traditional | PDF ↗ |
| K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2026-08-07 | Traditional | PDF ↗ |
| K260607 | Shield System (Siemens 30x40) | Radiaction , Ltd. | 2026-07-31 | Special | PDF ↗ |
| K253670 | SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. | 2026-07-10 | Abbreviated | PDF ↗ |
| K252735 | C-beam | Pulmera, Inc. | 2026-05-22 | Traditional | PDF ↗ |
| K252503 | Intelligent NR | Canon, Inc. | 2026-04-30 | Traditional | PDF ↗ |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | Siemens Medical Solutions USA, Inc. | 2026-04-24 | Traditional | PDF ↗ |
| K253752 | ARTIS genio floor; ARTIS icono.explore floor | Siemens Medical Solutions USA, Inc. | 2026-04-23 | Traditional | PDF ↗ |
| K252229 | BELLIGER ACE | Genoray Co., Ltd. | 2026-04-02 | Traditional | PDF ↗ |
| K252099 | Trinias | Shimadzu Corporation | 2026-03-24 | Abbreviated | PDF ↗ |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation | 2026-03-10 | Traditional | PDF ↗ |
| K252500 | CARA System | Cara Medical, Ltd. | 2026-02-20 | Traditional | PDF ↗ |
| K251992 | ArmSure Fluoroscopic Positioning System | Savfe Co. , Ltd. | 2026-02-11 | Traditional | PDF ↗ |
| K254186 | Azurion R3.1 | Philips Medical Systems B.V. | 2026-01-16 | Special | PDF ↗ |
| K252068 | MC2 Portable X-ray System | Oxos Medical | 2025-12-22 | Traditional | PDF ↗ |
| K251893 | SKAN C PULSAR | Skanray Technologies Limited | 2025-12-16 | Traditional | PDF ↗ |
| K251199 | Allia Moveo | GE Medical Systems SCS | 2025-12-09 | Traditional | PDF ↗ |
| K250241 | Cios Select | Siemens Medical Solutions USA, Inc. | 2025-11-04 | Traditional | PDF ↗ |
| K251827 | Azurion R3.1 | Philips Medical Systems B.V. | 2025-10-24 | Traditional | PDF ↗ |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Canon Medical Systems Corporation | 2025-10-10 | Traditional | PDF ↗ |
| K251523 | Cios Spin | Siemens Medical Solutions USA, Inc. | 2025-07-29 | Traditional | PDF ↗ |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | Brainlab AG | 2025-07-22 | Traditional | PDF ↗ |
| K250660 | LUMINOS Q.namix T; LUMINOS Q.namix R | Siemens Medical Solutions | 2025-07-14 | Traditional | PDF ↗ |
| K251520 | Cios Alpha; Cios Flow | Siemens Medical Solutions USA, Inc. | 2025-07-09 | Traditional | PDF ↗ |
| K243884 | TAVIPILOT | Caranx Medical | 2025-07-07 | Traditional | PDF ↗ |
| K250010 | EXTRON 3; EXTRON 5; EXTRON 7 | DRTECH Corporation | 2025-06-10 | Traditional | PDF ↗ |
| K243411 | Diagnostic X-ray System | Nanjing Perlove Medical Equipment Co., Ltd. | 2025-05-19 | Traditional | PDF ↗ |
| K242731 | MasteRad MiniX Mobile Digital Imaging System (Mini-X) | Medicatech USA, Inc. | 2025-05-16 | Traditional | PDF ↗ |
| K250282 | Persona C HR | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2025-04-30 | Traditional | PDF ↗ |
| K243376 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | 2025-04-28 | Traditional | PDF ↗ |
| K234067 | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) | Medphoton GmbH | 2025-03-28 | Traditional | PDF ↗ |
| K243646 | Ziehm Solo FD | Ziehm Imaging GmbH | 2025-03-17 | Traditional | PDF ↗ |
| K243735 | Ziehm Vision FD | Ziehm Imaging GmbH | 2025-03-13 | Traditional | PDF ↗ |
| K243446 | 3DXR | GE Medical Systems SCS | 2025-02-25 | Traditional | PDF ↗ |
| K243303 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2025-01-21 | Traditional | PDF ↗ |
| K243328 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2025-01-15 | Traditional | PDF ↗ |
| K241567 | MC2 Portable X-ray System | Oxos Medical | 2024-12-06 | Traditional | PDF ↗ |
| K241572 | ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) | Siemens Medical Solutions USA, Inc. | 2024-10-22 | Traditional | PDF ↗ |
| K233107 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 | Canon Medical Systems Corporation | 2024-08-30 | Traditional | PDF ↗ |
| K233230 | See Factor CT3 | Epica International, Inc. | 2024-06-21 | Traditional | PDF ↗ |
| K240465 | O-arm O2 Imaging System | Medtronic Navigation, Inc. | 2024-06-21 | Traditional | PDF ↗ |
| K240199 | IntraOp Alignment System | Alphatec Spine, Inc. | 2024-05-22 | Traditional | PDF ↗ |
| K240224 | Zenition 90 | Philips Medical Systems Nederlands B.V. | 2024-05-22 | Abbreviated | PDF ↗ |
| K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | Canon, Inc. | 2024-04-26 | Traditional | PDF ↗ |
| K233748 | CIARTIC Move (VB10) | Siemens Medical Solutions USA, Inc. | 2024-03-15 | Traditional | PDF ↗ |
| K232420 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2024-02-16 | Abbreviated | PDF ↗ |
| K240099 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2024-02-05 | Special | PDF ↗ |
| K240020 | Ziehm Vision FD | Ziehm Imaging GmbH | 2024-01-30 | Special | PDF ↗ |
| K234109 | Ziehm Solo FD | Ziehm Imaging GmbH | 2024-01-26 | Special | PDF ↗ |
| K230949 | ARTIS pheno (VE30A) | Siemens Medical Solutions USA, Inc. | 2023-12-15 | Traditional | PDF ↗ |
| K231700 | Ziehm Vision FD | Ziehm Imaging GmbH | 2023-12-15 | Special | PDF ↗ |
| K230950 | ARTIS icono (VE30A) | Siemens Medical Solutions USA, Inc. | 2023-12-14 | Traditional | PDF ↗ |
| K231669 | Ziehm Solo FD | Ziehm Imaging GmbH | 2023-12-12 | Special | PDF ↗ |
| K231692 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2023-11-20 | Special | PDF ↗ |
| K233200 | XPLUS 35 Series (XPLUS 35, XPLUS 35FD) | GEMSS HEALTHCARE CO., LTD. | 2023-11-16 | Traditional | PDF ↗ |
| K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | GE Medical Systems SCS | 2023-10-11 | Special | PDF ↗ |
| K230871 | EXTRON 5; EXTRON 7 | DRTECH Corporation | 2023-08-17 | Traditional | PDF ↗ |
| K230787 | Oscar 15 & Oscar 15i | Genoray Co., Ltd. | 2023-07-20 | Traditional | PDF ↗ |
| K231701 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2023-07-10 | Special | PDF ↗ |
| K222998 | F3 | Acrew Imaging, Inc. | 2023-06-20 | Traditional | PDF ↗ |
| K230185 | ANT-X System | Ndr Medical Technology Pte. , Ltd. | 2023-06-01 | Abbreviated | PDF ↗ |
| K221344 | nView s1 with nav option | Nview Medical | 2022-12-28 | Traditional | PDF ↗ |
| K223410 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | 2022-12-07 | Special | PDF ↗ |
| K223409 | Cios Select (VA21) Image Intensifier | Siemens Medical Solutions USA, Inc. | 2022-12-06 | Special | PDF ↗ |
| K213768 | Bolt Navigation System | Circinus Medical Technology, LLC | 2022-12-01 | Traditional | PDF ↗ |
| K221281 | Multitom Rax | Siemens Medical Solutions | 2022-11-17 | Traditional | PDF ↗ |
| K222070 | EndoNaut | Therenva Sas | 2022-10-25 | Traditional | PDF ↗ |
| K222080 | Garion Image-Intensified Fluoroscopic X-Ray System, Mobile | Sg Healthcare Co, Ltd. | 2022-10-06 | Traditional | PDF ↗ |
| K222625 | Shield System | Radiaction , Ltd. | 2022-09-30 | Special | PDF ↗ |
| K220342 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 | Canon Medical Systems Corporation | 2022-09-27 | Traditional | PDF ↗ |
| K221230 | TRON | Xoran Technologies, LLC | 2022-07-28 | Traditional | PDF ↗ |
| K221922 | Trinias | Shimadzu Corporation Medical Systems Division | 2022-07-28 | Special | PDF ↗ |
| K221516 | ARTIS icono (Ceiling Configuration) | Siemens Medical Solutions USA, Inc. | 2022-07-19 | Traditional | PDF ↗ |
| K220409 | ARTIS pheno (VE21) System | Siemens Medical Solutions USA, Inc. | 2022-06-29 | Traditional | PDF ↗ |
| K220432 | ARTIS icono (VE21) System | Siemens Medical Solutions USA, Inc. | 2022-06-29 | Traditional | PDF ↗ |
| K221335 | D²RS and D²RS 9090 | Stephanix | 2022-06-07 | Special | PDF ↗ |
| K220311 | Cardiovascular Angiography System | Allengers Medical Systems Limited | 2022-05-03 | Traditional | PDF ↗ |
| K220946 | SURGIVISIO Device | Ecential Robotics | 2022-04-15 | Special | PDF ↗ |
| K212159 | Shield System | Radiaction , Ltd. | 2022-03-30 | Traditional | PDF ↗ |
| K220627 | SURGIVISIO Device | Ecential Robotics | 2022-03-18 | Special | PDF ↗ |
| K211780 | ZEN-2090 Turbo | Genoray Co., Ltd. | 2022-03-09 | Traditional | PDF ↗ |
| K212212 | Multitom Rax with True2scale Body Scan Option | Siemens Medical Solutions | 2022-02-18 | Traditional | PDF ↗ |
| K213479 | D²RS and D²RS 9090 | Stephanix | 2021-12-23 | Traditional | PDF ↗ |
| K212442 | Cydar EV (Series B) and Cydar EV Maps | Cydar , Ltd. | 2021-12-03 | Traditional | PDF ↗ |
| K213455 | ControlRad Select Model Z | Controlrad, Inc. | 2021-11-24 | Special | PDF ↗ |
| K212336 | Soteria.AI | Omega Medical Imaging, LLC | 2021-11-17 | Traditional | PDF ↗ |
| K212956 | FDR Cross (DR-XD 3000) | Fujifilm Corporation | 2021-11-08 | Traditional | PDF ↗ |
| K212523 | VFSS Pro Mobile Digital Imaging System | Imagexray, LLC | 2021-11-05 | Traditional | PDF ↗ |
| K211064 | nView s1 with nav option | Nview Medical | 2021-10-29 | Traditional | PDF ↗ |
| K212813 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2021-10-01 | Special | PDF ↗ |
| K212557 | Virtual C DRF-NEO Digital Imaging System | Portavision Medical, LLC | 2021-09-24 | Traditional | PDF ↗ |
| K212383 | EndoNaut | Therenva Sas | 2021-08-31 | Special | PDF ↗ |
| K211777 | ARCO FP-S | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2021-08-13 | Traditional | PDF ↗ |
| K210912 | Excelsius3D | Globus Medical, Inc. | 2021-08-12 | Traditional | PDF ↗ |
| K211782 | ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 | Controlrad, Inc. | 2021-07-01 | Special | PDF ↗ |
| K211191 | Virtual C DRF Digital Imaging System | Portavision Medical, LLC | 2021-06-24 | Traditional | PDF ↗ |
| K203535 | Trinias | Shimadzu Corporation Medical Systems | 2021-04-28 | Traditional | PDF ↗ |
| K210900 | Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 | Canon Medical Systems Corporation | 2021-04-12 | Special | PDF ↗ |
| K203623 | StentBoost Mobile | Philips India Limited | 2021-04-05 | Abbreviated | PDF ↗ |
Product code OWB · Class II · Radiology. Data: openFDA.