The following data is part of a premarket notification filed by Dexcowin Co., Ltd with the FDA for Adx6000 Portable X-ray System; Iraya6.
| Device ID | K143494 |
| 510k Number | K143494 |
| Device Name: | ADX6000 Portable X-Ray System; IRayA6 |
| Classification | System, X-ray, Mobile |
| Applicant | DEXCOWIN CO., LTD No. 606, Woolim Lions Valley II 680 GEUMCHUN-GU Seoul, KR 153-776 |
| Contact | Ryu Seung-bum |
| Correspondent | Claude Berthoin DENTERPRISE INTERNATIONAL, INC. 110 EAST GRANADA BLVD SUITE 207 Ormond Beach, FL 32176 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-09 |
| Decision Date | 2015-10-05 |