The following data is part of a premarket notification filed by Ecotron Co.,ltd with the FDA for Epx-series Mobile X-ray System.
| Device ID | K151038 |
| 510k Number | K151038 |
| Device Name: | EPX-Series Mobile X-ray System |
| Classification | System, X-ray, Mobile |
| Applicant | ECOTRON CO.,LTD RM 504, HANSHIN IT TOWER II, 47, DIGITAL-RO 9-GIL GEUMCHEON-GU Seoul, KR 153-712 |
| Contact | Sang Bong Lee |
| Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817100020124 | K151038 | 000 |