The following data is part of a premarket notification filed by Drtech Corporation with the FDA for Evs 4343.
| Device ID | K142475 |
| 510k Number | K142475 |
| Device Name: | EVS 4343 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | DRTECH Corporation Suite No.2, 3 Floor Dunchon-dacro541beon-gil Jungwon-gu Seongam-si, KR 462-807 |
| Contact | Choul-woo Shin |
| Correspondent | Choul-woo Shin DRTECH Corporation Suite No.2, 3 Floor Dunchon-dacro541beon-gil Jungwon-gu Seongam-si, KR 462-807 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-03 |
| Decision Date | 2015-01-15 |
| Summary: | summary |