Atlas FDA

EHD

190 FDA 510(k) clearances · Product code

67 daysmedian time to decision
202 days90th percentile
190clearances measured

FDA profile

Official device name
Unit, X-Ray, Extraoral With Timer
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2014: 20 · 2015: 110 · 2016: 63 · 2017: 66 · 2018: 21 · 2019: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Portable Dental X-ray System Model PDX nova (K260367)PDX Co., Ltd.2026-05-27
NOMAD Pro 3 (K253864)Dental Imaging Technologies Corporation2026-03-20
Dental X-RAY Unit (AJX200) (K252110)Guangzhou Ajax Medical Equipment Co., Ltd.2026-03-12
Portable Dental X-ray Device (GT-1) (K254018)Guilin Refine Medical Instrument Co., Ltd.2026-02-19
Diagnostic X-Ray Equipment Model POCT22 (K252909)Ningbo Runyes Medical Instrument Co., Ltd.2026-02-03
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (K251438)Guilin Woodpecker Medical Instrument Co., Ltd.2025-09-04
Rextar Pro (K242185)Raypia Co., Ltd.2024-12-04
XERO-alpha (K242591)DRTECH Corporation2024-11-01
WERAY (K241963)Picopack Co., Ltd.2024-07-30
LifeRay Intraoral Handheld X-ray System (K241305)Lucas Lifecare2024-07-05
REMEX-GR100 (K240759)Remedi Co., Ltd.2024-05-13
XVbeam2000 (K233914)Shenzhen Xpectvision Technology Co., Ltd.2024-02-08
Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) (K233395)Alliage S/A Industrias Médico Odontológica2024-01-03
x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) (K231055)De Götzen S.R.L.2023-12-28
DVAS (DVAS-M, DVAS-W) (K232085)Genoray Co., Ltd.2023-12-08
N1 (K232012)Osstem Implant Co., Ltd.2023-11-28
HyperLight Portable X-ray Unit (K232068)Changzhou Sifary Medical Technology Co., Ltd.2023-09-01
Portable X-ray System Model Ray98(P) (K231449)Ningbo Runyes Medical Instrument Co., Ltd.2023-07-13
Lumos 3DX (K223780)3Dio2023-07-06
DHX-70H, XTG-70H (K221587)Digimed Co., Ltd.2023-03-03
Portable X-ray System (K223010)Iray Technology Taicang , Ltd.2023-01-17
Ai Ray Dental X-Ray Device (K222569)Guilin Woodpecker Medical Instrument Co., Ltd.2022-11-23
EzRay Air 2 Wall (Model: VEX-S350W) (K223058)VATECH Co., Ltd.2022-10-26
Hybrid C70 (K220579)Digimed Co., Ltd.2022-09-01
FONA XDC (K222274)Fona S.R.L2022-08-23
CLAROX (K221286)Vsi Co., Ltd.2022-06-29
DT-703 (K221233)Ecotron Co., Ltd.2022-06-27
HYBRID S70 (K220574)Digimed Co., Ltd.2022-04-22
ERI Handheld Dental X-ray System (Model AG100) (K213282)Energy Resources International Co., Ltd. Hsinchu Branch2022-04-04
Portray (K211014)Surround Medical Systems2021-07-28
Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) (K201800)Nanoray Co., Ltd.2020-12-28
EzRay Air Portable (Model: VEX-P300) (K200182)VATECH Co., Ltd.2020-02-11
Xcam (K192700)Hdx Will Corp.2019-12-27
EZER, Portable X-ray System (K190935)Livermoretech, Inc.2019-12-19
MINE (K180671)Rht Co., Ltd.2019-06-05
Star-X, Intraoral X-ray System (K190357)Hdx Will Corp.2019-03-15
RiX70 DC (K182206)Trident S.R.L2018-09-13
Portable X-ray System (Model: MiniX-V, Mini X-S) (K181891)Digimed Co., Ltd.2018-08-10
MobileX Portable X-ray System (K180561)Denterprise International, Inc.2018-04-04
Portable X-ray System (K172928)Rolence Enterprise, Inc.2018-03-16
PORT-X IV (K172810)Genoray Co., Ltd.2018-03-07
KaVo NOMAD Pro 2 Handheld X-ray System (K173319)Aribex2017-11-16
Intraskan DC Plus (K170967)Skanray Technologies Private Limited2017-06-08
EzRay Air W (K163705)VATECH Co., Ltd.2017-01-24
RX DC (K163519)Cefla S.C.2017-01-13
EzRay Air (Model VEX-P300) (K161063)VATECH Co., Ltd.2016-09-01
BI IMAGE-X EVOLUTION (K160458)Radiotecnologia Industrial S.A. DE C.V.2016-06-20
Portable X-ray System (Model: MINIX-V / MINIX-S) (K152859)Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012)2015-12-03
PHOT-X IIS MODEL 505 (K141293)Takara Belmont Corporation2014-09-03
PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) (K141497)Osstem Implant Co., Ltd.2014-08-26
X-MIND UNITY (K132378)De Gotzen S.R.L.2014-05-30
ENDOGRAPH DC (K130109)Villa Sistemi Medicali S.P.A.2013-08-01
REXTAR X (K132041)Meta Biomed, Inc.2013-07-31
PORTABLE X-RAY SYSTEM (K122124)Osstem Implant Co., Ltd.2013-05-16
REXTAR, REXTAR LCD (K122016)Meta Biomed, Inc.2013-03-01
VEX-S 100W INTRAORAL X-RAY SYSTEM (K123493)VATECH Co., Ltd.2012-12-13
DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) (K122582)Denterprise International, Inc.2012-12-07
AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY (K111330)Skanray Technologies2011-05-27
PORTABLE X-RAY SYSTEM (K103600)Digimed Corporation2011-04-08
INTRA SKAN DC (K103579)Skanray Technologies2011-03-18
VISTEO (K093105)Owandy2010-10-18
MINXRAY, MODEL: BPD60 (K091255)Minxray, Inc.2010-05-12
BELRAY II (K093240)Takara Belmont Corp.2010-03-22
PORTABLE X-RAY SYSTEM, MODEL HAND-RAY (K092772)Hanjin Digi-X Co., Ltd.2010-01-06
DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) (K092103)VATECH Co., Ltd.2009-10-09
PLANMECA PROSENSOR (K091197)Planmeca Oy2009-07-29
ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 (K090749)Villa Sistemi Medicali S.P.A.2009-05-18
PORTABLE X-RAY SYSTEM, MODEL DXR -1 (K082875)Exaro Co., Ltd.2009-02-05
HELIODENT PLUS (K083344)Sirona Dental Systems GmbH2008-12-23
PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX (K082167)Digimed Corporation2008-09-26
ANYRAY PORTABLE X-RAY SYSTEM (K081899)E-Woo Technology Co., Ltd.2008-08-21
NOMAD PRO X-RAY SYSTEM (K081664)Aribex, Inc.2008-06-23
RX DC X-RAY UNIT (K080076)Cefla S.C.R.L.2008-03-14
PORTABLE X-RAY SYSTEM, MODEL PORT-X II (K063121)Genoray Co., Ltd.2007-01-11
DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM (K060640)Dentamerica2006-04-24
KODAK MODELS 2100 AND 2200 (K060292)Kodak-Trophy2006-03-03
NOMAD DENTAL X-RAY SYSTEM (K051795)Aribex, Inc.2005-07-14
PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) (K051464)Planmeca Oy2005-06-24
ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 (K050255)Gendex Dental Systems2005-03-17
KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 (K043104)Practiceworks, Inc.2005-02-24
ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D (K043612)Instrumentarium Corp. Imaging Division2005-02-09
IN EXAM INTRAORAL DENTAL X-RAY SYSTEM (K050019)Kavo America2005-01-31
MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS (K043557)Panoramic Corp.2005-01-13
ELITY 70 X-RAY (K043136)Dental X-Ray E.U.2005-01-06
CRANEX D (K043307)Soredex Palodex Group OY2004-12-17
PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 (K043092)Progeny, Inc.2004-12-13
PHOT-X II, MODEL 303 (K042260)Takara Belmont USA, Inc.2004-09-07
CRANEX BASEX D OR CRANEX EXCEL D (K040382)Soredex Palodex Group OY2004-07-13
ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM (K040748)Takara Belmont USA, Inc.2004-06-02
MINRAY (K033755)Soredex Palodex Group OY2004-04-29
TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY (K040556)Eastman Kodak Company2004-04-07
TROPHYPAN AND TROPHYPAN C (K033690)Trophy Radiologie2004-02-20
ORTHOPHOS XG DS/CEPH (K033073)Sirona Dental Systems GmbH2003-10-10
ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW (K032355)Dentsply Gendex2003-09-25
RSV (RADIOLOGY SYSTEM VISIODENT (K031448)Visiodent SA2003-07-31
ENDOS DC (K030634)Villa Sistemi Medicali S.P.A.2003-07-21
CORIX 70 PLUS-USV (K031802)Coramex, S.A.2003-07-21
INTRAOS 70 (K031118)Blue X Imaging Srl2003-07-08
A/T X-RAY 70 (K024285)Air Techniques, Inc.2003-04-16
EVA DIGITAL DENTAL X-RAY SYSTEM (K030647)Afp Imaging Corp.2003-03-20
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