510(k) K252909
- Device
- Diagnostic X-Ray Equipment Model POCT22
- Applicant
- Ningbo Runyes Medical Instrument Co., Ltd.
- 510(k) number
- K252909
- Product code
- EHD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-03
- Date received
- 2025-09-12
- Regulation
- 872.1800
- Classification name
- Unit, X-Ray, Extraoral With Timer
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Weiqiong Fang
- Address
- # 456 Tonghui Rd. Jiangbei Investment & Pioneering Park C Ningbo Zhejiang CN 315000 315000
FDA Registration Numbers#
- 3015153900
- 3014398772
- 8044167
- 8043962
- 3005843418
- 9615782
- 3013511605
- 3010446656
- 3023861999
- 3003528079
- 3013779985
- 3014980469
- 3004706313
- 3021551875
- 1419489
- 3004884150
- 1054713
- 3008361230
- 3013099020
- 3029916103
- 2024949
- 3005172103
- 3009608361
- 3016875543
- 9614977
- 1423662
- 3005246977
- 3009134655
- 3008770655
- 3002819275
- 3014209556
- 1226003
- 2424472
- 3012649815
- 3005383085
- 3031886796
- 2024980
- 9611445
- 3011491794
- 3025308469
- 3006540014
- 3022107311
- 3015502499
- 8030876
- 3006610845
- 3002994636
- 3009001657
- 8020825
- 3003934980
- 3012187973
- 3008252267
- 3016075921
- 3005581016
- 3023546785
- 1526534
- 1523530
- 3010972172
- 9615832
- 3015376465
- 3007933232
Source Documents#
Other 510(k) Records For Product Code EHD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253864 | NOMAD Pro 3 | Dental Imaging Technologies Corporation | 2026-03-20 |
| K252110 | Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2026-03-12 |
| K254018 | Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., Ltd. | 2026-02-19 |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2025-09-04 |
| K242185 | Rextar Pro | Raypia Co., Ltd. | 2024-12-04 |
| K242591 | XERO-alpha | DRTECH Corporation | 2024-11-01 |
| K241963 | WERAY | Picopack Co., Ltd. | 2024-07-30 |
| K241305 | LifeRay Intraoral Handheld X-ray System | Lucas Lifecare | 2024-07-05 |
| K240759 | REMEX-GR100 | Remedi Co., Ltd. | 2024-05-13 |
| K233914 | XVbeam2000 | Shenzhen Xpectvision Technology Co., Ltd. | 2024-02-08 |
| K233395 | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | Alliage S/A Industrias Médico Odontológica | 2024-01-03 |
| K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | De Götzen S.R.L. | 2023-12-28 |
| K232085 | DVAS (DVAS-M, DVAS-W) | Genoray Co., Ltd. | 2023-12-08 |
| K232012 | N1 | Osstem Implant Co., Ltd. | 2023-11-28 |
| K232068 | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | 2023-09-01 |