FDA.report

510(k) K252099

Device
Trinias
Applicant
Shimadzu Corporation
510(k) number
K252099
Product code
OWB
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-24
Date received
2025-07-03
Regulation
892.1650
Classification name
Interventional Fluoroscopic X-Ray System
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Koichi Kataoka
Address
1, Nishinokyo Kuwabara-Cho, Nakagyo-Ku Kyoto JP 604-8511 604-8511

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

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K252503Intelligent NRCanon, Inc.2026-04-30
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K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.2026-04-23
K252229BELLIGER ACEGenoray Co., Ltd.2026-04-02
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