510(k) Report

Devices descending from K021378

48 later devices reach Portable HDX Intraoral X-Ray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051795Nomad Dental X-Ray SystemAribex, Inc.200547—
+2K232012N1Osstem Implant Co., Ltd.20230—
+2K081899Anyray Portable X-Ray SystemE-Woo Technology Co., Ltd.20080—
+2K081664Nomad Pro X-Ray SystemAribex, Inc.2008172
+2K070811Cordless Portable Dental X-Ray System, Model ADX4000Dexco20071—
+2K063121Portable X-Ray System, Model Port-X IIGenoray Co., Ltd.200724—
+3K172928Portable X-ray SystemRolence Enterprise, Inc.20180—
+3K173319KaVo NOMAD Pro 2 Handheld X-ray SystemAribex20179—
+3K161063EzRay Air (Model VEX-P300)VATECH Co., Ltd.20165—
+3K152859Portable X-ray System (Model: MINIX-V / MINIX-S)Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012)20157—
+3K122124Portable X-Ray SystemOsstem Implant Co., Ltd.20132—
+3K122016Rextar, Rextar LCDMeta Biomed, Inc.20138—
+3K103600Portable X-Ray SystemDigimed Corporation20118—
+3K092772Portable X-Ray System, Model Hand-RayHanjin Digi-X Co., Ltd.20100—
+3K083532ADX4000-L, DX3000-LDexcowin Co., Ltd.20090—
+3K082875Portable X-Ray System, Model DXR -1Exaro Co., Ltd.20090—
+3K082167Portable X-Ray System, Models Diox-602, ProxDigimed Corporation2008181
+4K253864NOMAD Pro 3Dental Imaging Technologies Corporation20260—
+4K241305LifeRay Intraoral Handheld X-ray SystemLucas Lifecare20240—
+4K233914XVbeam2000Shenzhen Xpectvision Technology Co., Ltd.20240—
+4K233395Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)Alliage S/A Industrias Médico Odontológica20240—
+4K221286ClaroxVsi Co., Ltd.20220—
+4K221233DT-703Ecotron Co., Ltd.20221—
+4K213282ERI Handheld Dental X-ray System (Model AG100)Energy Resources International Co., Ltd. Hsinchu Branch20220—
+4K201800Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)Nanoray Co., Ltd.20200—
+4K200182EzRay Air Portable (Model: VEX-P300)VATECH Co., Ltd.20204—
+4K180671MINERht Co., Ltd.20190—
+4K181891Portable X-ray System (Model: MiniX-V, Mini X-S)Digimed Co., Ltd.20180—
+4K180561MobileX Portable X-ray SystemDenterprise International, Inc.20185—
+4K141497Portable X-Ray System (Model:Exaro,XRAY2GO)Osstem Implant Co., Ltd.20140—
+4K132041Rextar XMeta Biomed, Inc.20137—
+5K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.20260—
+5K252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.20260—
+5K242185Rextar ProRaypia Co., Ltd.20240—
+5K242591XERO-alphaDRTECH Corporation20240—
+5K232068HyperLight Portable X-ray UnitChangzhou Sifary Medical Technology Co., Ltd.20232—
+5K231449Portable X-ray System Model Ray98(P)Ningbo Runyes Medical Instrument Co., Ltd.20231—
+5K221587DHX-70H, XTG-70HDigimed Co., Ltd.20230—
+5K222569Ai Ray Dental X-Ray DeviceGuilin Woodpecker Medical Instrument Co., Ltd.20221—
+5K220579Hybrid C70Digimed Co., Ltd.20220—
+5K220574Hybrid S70Digimed Co., Ltd.20220—
+5K192700XcamHdx Will Corp.20190—
+5K172810Port-X IVGenoray Co., Ltd.20181—
+6K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.20260—
+6K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.20260—
+6K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.20260—
+6K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )Guilin Woodpecker Medical Instrument Co., Ltd.20250—
+6K223010Portable X-ray SystemIray Technology Taicang, Ltd.20230—