The following data is part of a premarket notification filed by Drtech Corporation with the FDA for Evs 3643, Evs 3643g.
| Device ID | K162552 |
| 510k Number | K162552 |
| Device Name: | EVS 3643, EVS 3643G |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | DRTECH Corporation Suit No. 2, 3 Floor, 29, Dunchon-daero541 Beon-gil Jungwon-gu Seongnam-si, KR 13230 |
| Contact | Choul-woo Shin |
| Correspondent | Choul-woo Shin DRTECH Corporation Suit No. 2, 3 Floor, 29, Dunchon-daero541 Beon-gil Jungwon-gu Seongnam-si, KR 13230 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-13 |
| Decision Date | 2016-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800018402702 | K162552 | 000 |
| 08800018402603 | K162552 | 000 |