Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EHD — Predicate Candidate Screening
190 FDA 510(k) clearances under this product code; the 50 most recent screened below.
67 daysmedian FDA review time
202 days90th percentile
190clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260367 | Portable Dental X-ray System Model PDX nova | PDX Co., Ltd. | 2026-05-27 | 112 | 0 |
| K253864 | NOMAD Pro 3 | Dental Imaging Technologies Corporation | 2026-03-20 | 107 | 0 |
| K252110 | Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2026-03-12 | 248 | 0 |
| K254018 | Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., Ltd. | 2026-02-19 | 66 | 0 |
| K252909 | Diagnostic X-Ray Equipment Model POCT22 | Ningbo Runyes Medical Instrument Co., Ltd. | 2026-02-03 | 144 | 0 |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2025-09-04 | 118 | 0 |
| K242185 | Rextar Pro | Raypia Co., Ltd. | 2024-12-04 | 132 | 0 |
| K242591 | XERO-alpha | DRTECH Corporation | 2024-11-01 | 63 | 0 |
| K241963 | WERAY | Picopack Co., Ltd. | 2024-07-30 | 27 | 0 |
| K241305 | LifeRay Intraoral Handheld X-ray System | Lucas Lifecare | 2024-07-05 | 57 | 0 |
| K240759 | REMEX-GR100 | Remedi Co., Ltd. | 2024-05-13 | 54 | 0 |
| K233914 | XVbeam2000 | Shenzhen Xpectvision Technology Co., Ltd. | 2024-02-08 | 58 | 0 |
| K233395 | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR6 | Alliage S/A Industrias Médico Odontológica | 2024-01-03 | 92 | 0 |
| K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trad | De Götzen S.R.L. | 2023-12-28 | 259 | 0 |
| K232085 | DVAS (DVAS-M, DVAS-W) | Genoray Co., Ltd. | 2023-12-08 | 148 | 0 |
| K232012 | N1 | Osstem Implant Co., Ltd. | 2023-11-28 | 145 | 0 |
| K232068 | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | 2023-09-01 | 51 | 0 |
| K231449 | Portable X-ray System Model Ray98(P) | Ningbo Runyes Medical Instrument Co., Ltd. | 2023-07-13 | 56 | 0 |
| K223780 | Lumos 3DX | 3Dio | 2023-07-06 | 202 | 0 |
| K221587 | DHX-70H, XTG-70H | Digimed Co., Ltd. | 2023-03-03 | 275 | 0 |
| K223010 | Portable X-ray System | Iray Technology Taicang , Ltd. | 2023-01-17 | 110 | 0 |
| K222569 | Ai Ray Dental X-Ray Device | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-11-23 | 91 | 0 |
| K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | VATECH Co., Ltd. | 2022-10-26 | 26 | 0 |
| K220579 | Hybrid C70 | Digimed Co., Ltd. | 2022-09-01 | 192 | 0 |
| K222274 | FONA XDC | Fona S.R.L | 2022-08-23 | 25 | 0 |
| K221286 | CLAROX | Vsi Co., Ltd. | 2022-06-29 | 57 | 0 |
| K221233 | DT-703 | Ecotron Co., Ltd. | 2022-06-27 | 59 | 0 |
| K220574 | HYBRID S70 | Digimed Co., Ltd. | 2022-04-22 | 53 | 0 |
| K213282 | ERI Handheld Dental X-ray System (Model AG100) | Energy Resources International Co., Ltd. Hsinchu Branch | 2022-04-04 | 185 | 0 |
| K211014 | Portray | Surround Medical Systems | 2021-07-28 | 114 | 0 |
| K201800 | Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port- | Nanoray Co., Ltd. | 2020-12-28 | 181 | 0 |
| K200182 | EzRay Air Portable (Model: VEX-P300) | VATECH Co., Ltd. | 2020-02-11 | 18 | 0 |
| K192700 | Xcam | Hdx Will Corp. | 2019-12-27 | 92 | 0 |
| K190935 | EZER, Portable X-ray System | Livermoretech, Inc. | 2019-12-19 | 253 | 0 |
| K180671 | MINE | Rht Co., Ltd. | 2019-06-05 | 448 | 0 |
| K190357 | Star-X, Intraoral X-ray System | Hdx Will Corp. | 2019-03-15 | 28 | 0 |
| K182206 | RiX70 DC | Trident S.R.L | 2018-09-13 | 29 | 0 |
| K181891 | Portable X-ray System (Model: MiniX-V, Mini X-S) | Digimed Co., Ltd. | 2018-08-10 | 28 | 0 |
| K180561 | MobileX Portable X-ray System | Denterprise International, Inc. | 2018-04-04 | 30 | 0 |
| K172928 | Portable X-ray System | Rolence Enterprise, Inc. | 2018-03-16 | 172 | 0 |
| K172810 | PORT-X IV | Genoray Co., Ltd. | 2018-03-07 | 170 | 0 |
| K173319 | KaVo NOMAD Pro 2 Handheld X-ray System | Aribex | 2017-11-16 | 27 | 0 |
| K170967 | Intraskan DC Plus | Skanray Technologies Private Limited | 2017-06-08 | 69 | 0 |
| K163705 | EzRay Air W | VATECH Co., Ltd. | 2017-01-24 | 26 | 0 |
| K163519 | RX DC | Cefla S.C. | 2017-01-13 | 29 | 0 |
| K161063 | EzRay Air (Model VEX-P300) | VATECH Co., Ltd. | 2016-09-01 | 139 | 0 |
| K160458 | BI IMAGE-X EVOLUTION | Radiotecnologia Industrial S.A. DE C.V. | 2016-06-20 | 122 | 0 |
| K152859 | Portable X-ray System (Model: MINIX-V / MINIX-S) | Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) | 2015-12-03 | 64 | 0 |
| K141293 | PHOT-X IIS MODEL 505 | Takara Belmont Corporation | 2014-09-03 | 107 | 0 |
| K141497 | PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) | Osstem Implant Co., Ltd. | 2014-08-26 | 81 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda