Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Unit, X-Ray, Extraoral With Timer

FDA product code EHD · 187 cleared devices

Class 2 Dental

Regulation: 21 CFR 872.1800
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-12-02 – 2026-09-14

EHD 2026-09-14

Hand-held Dental X-ray System (HyperLight-M)

Applicant Changzhou Sifary Medical Technology Co., Ltd.

K number K260795

View details →

EHD 2026-05-27

Portable Dental X-ray System Model PDX nova

Applicant PDX Co., Ltd.

K number K260367

View details →

EHD 2026-03-20

NOMAD Pro 3

Applicant Dental Imaging Technologies Corporation

K number K253864

View details →

EHD 2026-03-12

Dental X-RAY Unit (AJX200)

Applicant Guangzhou Ajax Medical Equipment Co., Ltd.

K number K252110

View details →

EHD 2026-02-19

Portable Dental X-ray Device (GT-1)

Applicant Guilin Refine Medical Instrument Co., Ltd.

K number K254018

View details →

EHD 2026-02-03

Diagnostic X-Ray Equipment Model POCT22

Applicant Ningbo Runyes Medical Instrument Co., Ltd.

K number K252909

View details →

EHD 2025-09-04

Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K number K251438

View details →

EHD 2024-12-04

Rextar Pro

Applicant Raypia Co., Ltd.

K number K242185

View details →

EHD 2024-11-01

XERO-alpha

Applicant DRTECH Corporation

K number K242591

View details →

EHD 2024-07-30

WERAY

Applicant Picopack Co., Ltd.

K number K241963

View details →

EHD 2024-07-05

LifeRay Intraoral Handheld X-ray System

Applicant Lucas Lifecare

K number K241305

View details →

EHD 2024-05-13

REMEX-GR100

Applicant Remedi Co., Ltd.

K number K240759

View details →

EHD 2024-02-08

XVbeam2000

Applicant Shenzhen Xpectvision Technology Co., Ltd.

K number K233914

View details →

EHD 2024-01-03

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)

Applicant Alliage S/A Industrias Médico Odontológica

K number K233395

View details →

EHD 2023-12-28

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

Applicant De Götzen S.R.L.

K number K231055

View details →

EHD 2023-12-08

DVAS (DVAS-M, DVAS-W)

Applicant Genoray Co., Ltd.

K number K232085

View details →

EHD 2023-11-28

N1

Applicant Osstem Implant Co., Ltd.

K number K232012

View details →

EHD 2023-09-01

HyperLight Portable X-ray Unit

Applicant Changzhou Sifary Medical Technology Co., Ltd.

K number K232068

View details →

EHD 2023-07-13

Portable X-ray System Model Ray98(P)

Applicant Ningbo Runyes Medical Instrument Co., Ltd.

K number K231449

View details →

EHD 2023-07-06

Lumos 3DX

Applicant 3Dio

K number K223780

View details →

EHD 2023-03-03

DHX-70H, XTG-70H

Applicant Digimed Co., Ltd.

K number K221587

View details →

EHD 2023-01-17

Portable X-ray System

Applicant Iray Technology Taicang , Ltd.

K number K223010

View details →

EHD 2022-11-23

Ai Ray Dental X-Ray Device

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K number K222569

View details →

EHD 2022-10-26

EzRay Air 2 Wall (Model: VEX-S350W)

Applicant VATECH Co., Ltd.

K number K223058

View details →

EHD 2022-09-01

Hybrid C70

Applicant Digimed Co., Ltd.

K number K220579

View details →

EHD 2022-08-23

FONA XDC

Applicant Fona S.R.L

K number K222274

View details →

EHD 2022-06-29

CLAROX

Applicant Vsi Co., Ltd.

K number K221286

View details →

EHD 2022-06-27

DT-703

Applicant Ecotron Co., Ltd.

K number K221233

View details →

EHD 2022-04-22

HYBRID S70

Applicant Digimed Co., Ltd.

K number K220574

View details →

EHD 2022-04-04

ERI Handheld Dental X-ray System (Model AG100)

Applicant Energy Resources International Co., Ltd. Hsinchu Branch

K number K213282

View details →

EHD 2021-07-28

Portray

Applicant Surround Medical Systems

K number K211014

View details →

EHD 2020-12-28

Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)

Applicant Nanoray Co., Ltd.

K number K201800

View details →

EHD 2020-02-11

EzRay Air Portable (Model: VEX-P300)

Applicant VATECH Co., Ltd.

K number K200182

View details →

EHD 2019-12-27

Xcam

Applicant Hdx Will Corp.

K number K192700

View details →

EHD 2019-12-19

EZER, Portable X-ray System

Applicant Livermoretech, Inc.

K number K190935

View details →

EHD 2019-06-05

MINE

Applicant Rht Co., Ltd.

K number K180671

View details →

EHD 2019-03-15

Star-X, Intraoral X-ray System

Applicant Hdx Will Corp.

K number K190357

View details →

EHD 2018-09-13

RiX70 DC

Applicant Trident S.R.L

K number K182206

View details →

EHD 2018-08-10

Portable X-ray System (Model: MiniX-V, Mini X-S)

Applicant Digimed Co., Ltd.

K number K181891

View details →

EHD 2018-04-04

MobileX Portable X-ray System

Applicant Denterprise International, Inc.

K number K180561

View details →

EHD 2018-03-16

Portable X-ray System

Applicant Rolence Enterprise, Inc.

K number K172928

View details →

EHD 2018-03-07

PORT-X IV

Applicant Genoray Co., Ltd.

K number K172810

View details →

EHD 2017-11-16

KaVo NOMAD Pro 2 Handheld X-ray System

Applicant Aribex

K number K173319

View details →

EHD 2017-06-08

Intraskan DC Plus

Applicant Skanray Technologies Private Limited

K number K170967

View details →

EHD 2017-01-24

EzRay Air W

Applicant VATECH Co., Ltd.

K number K163705

View details →

EHD 2017-01-13

RX DC

Applicant Cefla S.C.

K number K163519

View details →

EHD 2016-09-01

EzRay Air (Model VEX-P300)

Applicant VATECH Co., Ltd.

K number K161063

View details →

EHD 2016-06-20

BI IMAGE-X EVOLUTION

Applicant Radiotecnologia Industrial S.A. DE C.V.

K number K160458

View details →

EHD 2013-08-01

ENDOGRAPH DC

Applicant Villa Sistemi Medicali S.P.A.

K number K130109

View details →

EHD 2013-07-31

REXTAR X

Applicant Meta Biomed, Inc.

K number K132041

View details →

EHD 2013-05-16

PORTABLE X-RAY SYSTEM

Applicant Osstem Implant Co., Ltd.

K number K122124

View details →

EHD 2013-03-01

REXTAR, REXTAR LCD

Applicant Meta Biomed, Inc.

K number K122016

View details →

EHD 2012-12-13

VEX-S 100W INTRAORAL X-RAY SYSTEM

Applicant VATECH Co., Ltd.

K number K123493

View details →

EHD 2012-12-07

DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)

Applicant Denterprise International, Inc.

K number K122582

View details →

EHD 2011-05-27

AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY

Applicant Skanray Technologies

K number K111330

View details →

EHD 2011-04-08

PORTABLE X-RAY SYSTEM

Applicant Digimed Corporation

K number K103600

View details →

EHD 2011-03-18

INTRA SKAN DC

Applicant Skanray Technologies

K number K103579

View details →

EHD 2010-10-18

VISTEO

Applicant Owandy

K number K093105

View details →

EHD 2010-05-12

MINXRAY, MODEL: BPD60

Applicant Minxray, Inc.

K number K091255

View details →

EHD 2010-03-22

BELRAY II

Applicant Takara Belmont Corp.

K number K093240

View details →

EHD 2010-01-06

PORTABLE X-RAY SYSTEM, MODEL HAND-RAY

Applicant Hanjin Digi-X Co., Ltd.

K number K092772

View details →

EHD 2009-10-09

DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)

Applicant VATECH Co., Ltd.

K number K092103

View details →

EHD 2009-07-29

PLANMECA PROSENSOR

Applicant Planmeca Oy

K number K091197

View details →

EHD 2009-05-18

ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191

Applicant Villa Sistemi Medicali S.P.A.

K number K090749

View details →

EHD 2009-02-05

PORTABLE X-RAY SYSTEM, MODEL DXR -1

Applicant Exaro Co., Ltd.

K number K082875

View details →

EHD 2008-12-23

HELIODENT PLUS

Applicant Sirona Dental Systems GmbH

K number K083344

View details →

EHD 2008-09-26

PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX

Applicant Digimed Corporation

K number K082167

View details →

EHD 2008-08-21

ANYRAY PORTABLE X-RAY SYSTEM

Applicant E-Woo Technology Co., Ltd.

K number K081899

View details →

EHD 2008-06-23

NOMAD PRO X-RAY SYSTEM

Applicant Aribex, Inc.

K number K081664

View details →

EHD 2008-03-14

RX DC X-RAY UNIT

Applicant Cefla S.C.R.L.

K number K080076

View details →

EHD 2007-01-11

PORTABLE X-RAY SYSTEM, MODEL PORT-X II

Applicant Genoray Co., Ltd.

K number K063121

View details →

EHD 2006-04-24

DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM

Applicant Dentamerica

K number K060640

View details →

EHD 2006-03-03

KODAK MODELS 2100 AND 2200

Applicant Kodak-Trophy

K number K060292

View details →

EHD 2005-07-14

NOMAD DENTAL X-RAY SYSTEM

Applicant Aribex, Inc.

K number K051795

View details →

EHD 2005-06-24

PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)

Applicant Planmeca Oy

K number K051464

View details →

EHD 2005-03-17

ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4

Applicant Gendex Dental Systems

K number K050255

View details →

EHD 2005-02-24

KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0

Applicant Practiceworks, Inc.

K number K043104

View details →

EHD 2005-02-09

ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D

Applicant Instrumentarium Corp. Imaging Division

K number K043612

View details →

EHD 2005-01-31

IN EXAM INTRAORAL DENTAL X-RAY SYSTEM

Applicant Kavo America

K number K050019

View details →

EHD 2005-01-13

MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS

Applicant Panoramic Corp.

K number K043557

View details →

EHD 2005-01-06

ELITY 70 X-RAY

Applicant Dental X-Ray E.U.

K number K043136

View details →

EHD 2004-12-17

CRANEX D

Applicant Soredex Palodex Group OY

K number K043307

View details →

EHD 2004-12-13

PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015

Applicant Progeny, Inc.

K number K043092

View details →

EHD 2004-09-07

PHOT-X II, MODEL 303

Applicant Takara Belmont USA, Inc.

K number K042260

View details →

EHD 2004-07-13

CRANEX BASEX D OR CRANEX EXCEL D

Applicant Soredex Palodex Group OY

K number K040382

View details →

EHD 2004-06-02

ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM

Applicant Takara Belmont USA, Inc.

K number K040748

View details →

EHD 2004-04-29

MINRAY

Applicant Soredex Palodex Group OY

K number K033755

View details →

EHD 2004-04-07

TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY

Applicant Eastman Kodak Company

K number K040556

View details →

EHD 2004-02-20

TROPHYPAN AND TROPHYPAN C

Applicant Trophy Radiologie

K number K033690

View details →

EHD 2003-10-10

ORTHOPHOS XG DS/CEPH

Applicant Sirona Dental Systems GmbH

K number K033073

View details →

EHD 2003-09-25

ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW

Applicant Dentsply Gendex

K number K032355

View details →

EHD 2003-07-31

RSV (RADIOLOGY SYSTEM VISIODENT

Applicant Visiodent SA

K number K031448

View details →

EHD 2003-07-21

CORIX 70 PLUS-USV

Applicant Coramex, S.A.

K number K031802

View details →

EHD 2003-07-21

ENDOS DC

Applicant Villa Sistemi Medicali S.P.A.

K number K030634

View details →

EHD 2003-07-08

INTRAOS 70

Applicant Blue X Imaging Srl

K number K031118

View details →

EHD 2003-04-16

A/T X-RAY 70

Applicant Air Techniques, Inc.

K number K024285

View details →

EHD 2003-03-20

EVA DIGITAL DENTAL X-RAY SYSTEM

Applicant Afp Imaging Corp.

K number K030647

View details →

EHD 2003-03-11

ENDOS AC/ACP

Applicant Villa Sistemi Medicali S.P.A.

K number K030185

View details →

EHD 2002-10-09

MODIFICATION TO FOCUS

Applicant Instrumentarium Corp.

K number K022630

View details →

EHD 2002-06-07

PORTABLE HDX INTRAORAL X-RAY

Applicant Dentalez Group

K number K021378

View details →

↑