The following data is part of a premarket notification filed by Digimed Co., Ltd. with the FDA for Portable X-ray System (model: Minix-v, Mini X-s).
| Device ID | K181891 |
| 510k Number | K181891 |
| Device Name: | Portable X-ray System (Model: MiniX-V, Mini X-S) |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | Digimed Co., LTD. 309-311, 318-ho, 145, Gasan Digital 1-ro, Geumcheon-gu Seoul, KR 08506 |
| Contact | Youngbae Kwon |
| Correspondent | Yong Park Innoden LLC 212 Wells Ave. S #102 Renton, WA 98057 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-13 |
| Decision Date | 2018-08-10 |
| Summary: | summary |