The following data is part of a premarket notification filed by Drtech Corporation with the FDA for Expd 4343p, Expd 3643p.
| Device ID | K193031 |
| 510k Number | K193031 |
| Device Name: | EXPD 4343P, EXPD 3643P |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | DRTECH Corporation Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero541 Beon-gil, Jungwon-gu, Seongam-si, KR 13216 |
| Contact | Dongwook Shin |
| Correspondent | Dongwook Shin DRTECH Corporation Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero541 Beon-gil, Jungwon-gu, Seongam-si, KR 13216 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-30 |
| Decision Date | 2019-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800018406304 | K193031 | 000 |
| 08800018406205 | K193031 | 000 |