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OWB

Interventional Fluoroscopic X-Ray System

Product code
OWB
Device name
Interventional Fluoroscopic X-Ray System
Device class
Class 2
21 CFR
21 CFR 892.1650
Medical specialty
Radiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
325

FDA classification definition

Interventional fluoroscopy

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (57)

Last three years. Most recent: 2026-08-21.

NumberDecision dateApplicantDevice name
K2537262026-08-21Shanghai United Imaging Healthcare Co.uAngio AVIVA CX summary
K2614132026-08-19DRTECH CorporationEXTRON 3;EXTRON 6 summary
K2542052026-08-07Philips Medical Systems Nederland B.V.Zenition 30 summary
K2606072026-07-31Radiaction , Ltd.Shield System (Siemens 30x40) summary
K2536702026-07-10Philips Medical Systems B.V.SmartCT (R3.0 (L10)) summary
K2527352026-05-22Pulmera, Inc.C-beam summary
K2525032026-04-30Canon, Inc.Intelligent NR summary
K2541732026-04-24Siemens Medical Solutions USA, Inc.ARTIS icono floor; ARTIS icono biplane; ARTIS icono summary
K2537522026-04-23Siemens Medical Solutions USA, Inc.ARTIS genio floor; ARTIS icono.explore floor summary
K2522292026-04-02Genoray Co., Ltd.BELLIGER ACE summary
K2520992026-03-24Shimadzu CorporationTrinias summary
K2535842026-03-10Canon Medical Systems CorporationAlphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvo summary
K2525002026-02-20Cara Medical, Ltd.CARA System summary
K2519922026-02-11Savfe Co. , Ltd.ArmSure Fluoroscopic Positioning System summary
K2541862026-01-16Philips Medical Systems B.V.Azurion R3.1 summary
K2520682025-12-22Oxos MedicalMC2 Portable X-ray System summary
K2518932025-12-16Skanray Technologies LimitedSKAN C PULSAR summary
K2511992025-12-09GE Medical Systems SCSAllia Moveo summary
K2502412025-11-04Siemens Medical Solutions USA, Inc.Cios Select summary
K2518272025-10-24Philips Medical Systems B.V.Azurion R3.1 summary
K2516022025-10-10Canon Medical Systems CorporationAlphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvo summary
K2515232025-07-29Siemens Medical Solutions USA, Inc.Cios Spin summary
K2434322025-07-22Brainlab AGVascular Navigation PAD 2.0; Navigation Software Vas summary
K2506602025-07-14Siemens Medical SolutionsLUMINOS Q.namix T; LUMINOS Q.namix R summary
K2515202025-07-09Siemens Medical Solutions USA, Inc.Cios Alpha; Cios Flow summary
K2438842025-07-07Caranx MedicalTAVIPILOT summary
K2500102025-06-10DRTECH CorporationEXTRON 3; EXTRON 5; EXTRON 7 summary
K2434112025-05-19Nanjing Perlove Medical Equipment Co.,Diagnostic X-ray System summary
K2427312025-05-16Medicatech USA, Inc.MasteRad MiniX Mobile Digital Imaging System (Mini-X summary
K2502822025-04-30A.T.S. Applicazione Tecnologie SpecialPersona C HR summary
K2433762025-04-28Shanghai United Imaging Healthcare Co.uAngio AVIVA CX summary
K2340672025-03-28Medphoton GmbHImagingRing m (Version 2.0); Loop-X (Version 2.0); L summary
K2436462025-03-17Ziehm Imaging GmbHZiehm Solo FD summary
K2437352025-03-13Ziehm Imaging GmbHZiehm Vision FD summary
K2434462025-02-25GE Medical Systems SCS3DXR summary
K2433032025-01-21Ziehm Imaging GmbHZiehm Vision RFD 3D summary
K2433282025-01-15Ziehm Imaging GmbHZiehm Vision RFD summary
K2415672024-12-06Oxos MedicalMC2 Portable X-ray System summary
K2415722024-10-22Siemens Medical Solutions USA, Inc.ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (bi summary
K2331072024-08-30Canon Medical Systems CorporationAlphenix, INFX-8000V/B, INFX-8000V/S, V9.5 summary
K2332302024-06-21Epica International, Inc.See Factor CT3™ summary
K2404652024-06-21Medtronic Navigation, Inc.O-arm O2 Imaging System summary
K2401992024-05-22Alphatec Spine, Inc.IntraOp Alignment System summary
K2402242024-05-22Philips Medical Systems Nederlands B.VZenition 90 summary
K2322982024-04-26Canon, Inc.DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl summary
K2337482024-03-15Siemens Medical Solutions USA, Inc.CIARTIC Move (VB10) summary
K2324202024-02-16Philips Medical Systems Nederland B.V.Zenition 30 summary
K2400992024-02-05Ziehm Imaging GmbHZiehm Vision RFD summary
K2400202024-01-30Ziehm Imaging GmbHZiehm Vision FD summary
K2341092024-01-26Ziehm Imaging GmbHZiehm Solo FD summary
K2317002023-12-15Ziehm Imaging GmbHZiehm Vision FD summary
K2309492023-12-15Siemens Medical Solutions USA, Inc.ARTIS pheno (VE30A) summary
K2309502023-12-14Siemens Medical Solutions USA, Inc.ARTIS icono (VE30A) summary
K2316692023-12-12Ziehm Imaging GmbHZiehm Solo FD summary
K2316922023-11-20Ziehm Imaging GmbHZiehm Vision RFD summary
K2332002023-11-16GEMSS HEALTHCARE CO., LTD.XPLUS 35 Series (XPLUS 35, XPLUS 35FD) summary
K2323442023-10-11GE Medical Systems SCSAllia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 O summary
Official FDA classification page: OWB
Classification and pathway per current FDA publications. Data from openFDA (CC0).