510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K203551Substantially Equivalent

Alphenix, INFX-8000V/B, /S, V9.1

Canon Medical Systems Corporation, Otawara-Shi, JP / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203551 is the FDA 510(k) clearance record for Alphenix, INFX-8000V/B, /S, V9.1, a class II device, cleared for Canon Medical Systems Corporation on under FDA product code OWB (Interventional Fluoroscopic X-Ray System). FDA's definition for product code OWB reads: "Interventional fluoroscopy". FDA records list 97 510(k) clearances for Canon Medical Systems Corporation, from to . As of , FDA records show one recall naming K203551.

Clearance record

Decision date
Received
(14 days to decision)
Product code
OWB Interventional Fluoroscopic X-Ray System
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Applicant
Canon Medical Systems Corporation 1385 Shimoishigami, Otawara-Shi, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWB

Trailing 12 months
19 clearances under product code OWB in the twelve months to October 2026, April 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code OWB, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20262
March 20262
April 20264
May 20261
June 20260
July 20262
August 20263
September 20260
October 20260