The following data is part of a premarket notification filed by Drtech Corporation with the FDA for Expd 86p, Expd 86pg, Expd 129p, Expd 129pg.
| Device ID | K223124 |
| 510k Number | K223124 |
| Device Name: | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | DRTECH Corporation Suite No. 1, 2 Floor/Suite No. 2, 3 Floor, 29, Dunchon-daero 541beon-gil Jungwon-gu, Seongnam-si, KR 13216 |
| Contact | Ella An |
| Correspondent | Ella An DRTECH Corporation Suite No. 1, 2 Floor/Suite No. 2, 3 Floor, 29, Dunchon-daero 541beon-gil Jungwon-gu, Seongnam-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 | 2022-10-03 |
| Decision Date | 2022-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800018407608 | K223124 | 000 |
| 08800018407509 | K223124 | 000 |
| 08800018407400 | K223124 | 000 |
| 08800018407301 | K223124 | 000 |