DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl

FDA 510(k) K232298 · Canon, Inc.

Substantially Equivalent

510(k) numberK232298

Submission

Device name
DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
Applicant
Canon, Inc.
Kawasaki, JP
Received
August 1, 2023
Decision date
April 26, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OWB – Interventional Fluoroscopic X-Ray System
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

Interventional fluoroscopy

Other 510(k)s with product code OWB

510(k)DeviceApplicantDecision
K253726uAngio AVIVA CXOWB · Traditional Shanghai United Imaging Healthcare Co., Ltd.08/21/2026SE
K261413Extron 3;EXTRON 6OWB · Traditional DRTECH Corporation08/19/2026SE
K254205Zenition 30OWB · Traditional Philips Medical Systems Nederland B.V.08/07/2026SE
K260607Shield System (Siemens 30x40)OWB · Special Radiaction , Ltd.07/31/2026SE
K253670SmartCT (R3.0 (L10))OWB · Abbreviated Philips Medical Systems B.V.07/10/2026SE
K252735C-beamOWB · Traditional Pulmera, Inc.05/22/2026SE
K252503Intelligent NROWB · Traditional Canon, Inc.04/30/2026SE
K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional Siemens Medical Solutions USA, Inc.04/24/2026SE
K253752ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional Siemens Medical Solutions USA, Inc.04/23/2026SE
K252229Belliger AceOWB · Traditional Genoray Co., Ltd.04/02/2026SE

More from Genoray Co., Ltd.

510(k)DeviceDecision
K252503Intelligent NROWB · Traditional 04/30/2026SE
K241049CANON Fundus Camera CR-10 (CR-10)HKI · Special 05/15/2024SE
K230175Digital Radiography CXDI-CS01MQB · Special 02/15/2023SE
K222855Digital Radiography CXDI-Pro, Digital Radiography D1MQB · Special 10/17/2022SE
K222687Digital Radiography CXDI-Elite, Digital Radiography E1MQB · Special 09/29/2022SE
K222661Digital Radiography CXDI-CS01MQB · Special 09/27/2022SE
K221876Digital Radiography CXDI-Pro, Digital Radiography D1MQB · Special 07/15/2022SE
K221620Digital Radiography CXDI-Elite, Digital Radiography E1MQB · Special 06/14/2022SE
K220098Digital Radiography CXDI-Pro, Digital Radiography D1MQB · Special 02/04/2022SE
K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1MQB · Traditional 01/24/2022SE

Questions and answers

When was DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl cleared by the FDA?

DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl (K232298) received a 510(k) decision of Substantially Equivalent on April 26, 2024, 269 days after the submission was received.

What is the product code of K232298?

The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.