Home / Device Classification / EHD

EHD — Unit, X-Ray, Extraoral With Timer Class II

FDA Device Classification

Classification Details

Product Code
EHD
Device Class
Class II
Regulation Number
872.1800
Submission Type
Review Panel
RA
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252110guangzhou ajax medical equipment coDental X-RAY Unit (AJX200)March 12, 2026
K254018guilin refine medical instrument coPortable Dental X-ray Device (GT-1)February 19, 2026
K252909ningbo runyes medical instrument coDiagnostic X-Ray Equipment Model POCT22February 3, 2026
K251438guilin woodpecker medical instrument coDental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )September 4, 2025
K242185raypia coRextar ProDecember 4, 2024
K242591drtech corporationXERO-alphaNovember 1, 2024
K241963picopack coWERAYJuly 30, 2024
K241305lucas lifecareLifeRay Intraoral Handheld X-ray SystemJuly 5, 2024
K240759remedi coREMEX-GR100May 13, 2024
K233914shenzhen xpectvision technology coXVbeam2000February 8, 2024
K233395alliage s/a industrias médico odontológicaPortable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)January 3, 2024
K231055de götzenx-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiologDecember 28, 2023
K232085genoray coDVAS (DVAS-M, DVAS-W)December 8, 2023
K232012osstem implant coN1November 28, 2023
K232068changzhou sifary medical technology coHyperLight Portable X-ray UnitSeptember 1, 2023
K231449ningbo runyes medical instrument coPortable X-ray System Model Ray98(P)July 13, 2023
K2237803dioLumos 3DXJuly 6, 2023
K221587digimed coDHX-70H, XTG-70HMarch 3, 2023
K223010iray technology taicangPortable X-ray SystemJanuary 17, 2023
K222569guilin woodpecker medical instrument coAi Ray Dental X-Ray DeviceNovember 23, 2022