510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231055Substantially Equivalent

x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)

De Gotzen S.r.l., Fagnano Olona, IT / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231055 is the FDA 510(k) clearance record for x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology), a class II device, cleared for De Götzen S.R.L. on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list 7 510(k) clearances for De Götzen S.R.L., from to . As of , FDA records show no recalls naming K231055.

Clearance record

Decision date
Received
(259 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
De Götzen S.R.L. Strada Provinciale Busto-Cassano 3, Fagnano Olona, IT
510(k) summary
Summary PDF
Third party review
No

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