FDA.report

510(k) K252503

Device
Intelligent NR
Applicant
Canon, Inc.
510(k) number
K252503
Product code
OWB
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-30
Date received
2025-08-08
Regulation
892.1650
Classification name
Interventional Fluoroscopic X-Ray System
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Masahiro Abe
Address
30-2, Shimomaruko 3-Chome Ohta-Ku Tokyo JP 146-8501 146-8501

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code OWB

510(k)DeviceApplicantDecision date
K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.2026-04-24
K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.2026-04-23
K252229BELLIGER ACEGenoray Co., Ltd.2026-04-02
K252099TriniasShimadzu Corporation2026-03-24
K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation2026-03-10
K252500CARA SystemCara Medical, Ltd.2026-02-20
K251992ArmSure Fluoroscopic Positioning SystemSavfe Co. , Ltd.2026-02-11
K254186Azurion R3.1Philips Medical Systems B.V.2026-01-16
K252068MC2 Portable X-ray SystemOxos Medical2025-12-22
K251893SKAN C PULSARSkanray Technologies Limited2025-12-16
K251199Allia MoveoGE Medical Systems SCS2025-12-09
K250241Cios SelectSiemens Medical Solutions USA, Inc.2025-11-04
K251827Azurion R3.1Philips Medical Systems B.V.2025-10-24
K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation2025-10-10
K251523Cios SpinSiemens Medical Solutions USA, Inc.2025-07-29