The following data is part of a premarket notification filed by Digimed Co., Ltd. (digimed Corporation Until 31/12/2012) with the FDA for Portable X-ray System (model: Minix-v / Minix-s).
| Device ID | K152859 |
| 510k Number | K152859 |
| Device Name: | Portable X-ray System (Model: MINIX-V / MINIX-S) |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012) 309-311, 318-HO, 145, GRASAN DIGITAL 1-RO, GEUMCHEON-GU Seoul, KR 153-787 |
| 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 | 2015-09-30 |
| Decision Date | 2015-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858475006092 | K152859 | 000 |