510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103425Substantially Equivalent

Zen-7000, Fluoroscopic X-Ray System

Genoray America Inc., Orange CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103425 is the FDA 510(k) clearance record for ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM, a class II device, cleared for Genoray America, Inc. on under FDA product code OWB (Interventional Fluoroscopic X-Ray System). FDA's definition for product code OWB reads: "Interventional fluoroscopy". FDA records list one 510(k) clearance for Genoray America, Inc. As of , FDA records show no recalls naming K103425.

Clearance record

Decision date
Received
(127 days to decision)
Product code
OWB Interventional Fluoroscopic X-Ray System
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Applicant
Genoray America, Inc. 1073 N. Batavia St., Orange CA
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