510(k) K232298

DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl by Canon, Inc. — Product Code OWB

K232298 is an FDA 510(k) premarket notification submitted by Canon, Inc. for the device "DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl". The FDA issued a decision of Substantially Equivalent on April 26, 2024. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Canon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2024
Date Received
August 1, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy