510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063121Substantially Equivalent

Portable X-Ray System, Model Port-X II

Genoray Co., Ltd., Flintville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063121 is the FDA 510(k) clearance record for PORTABLE X-RAY SYSTEM, MODEL PORT-X II, a class II device, cleared for Genoray Co., Ltd. on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list 24 510(k) clearances for Genoray Co., Ltd., from to . As of , FDA records show no recalls naming K063121.

Clearance record

Decision date
Received
(91 days to decision)
Product code
EHD Unit, X-Ray, Extraoral With Timer
Regulation
21 CFR 872.1800
Device class
Class II
Review panel
Dental
Applicant
Genoray Co., Ltd. 340 Shady Grove Rd., Flintville TN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code EHD

Trailing 12 months
6 clearances under product code EHD in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EHD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20262
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260