The following data is part of a premarket notification filed by Drtech Corporation with the FDA for Rsm 1824c With Rconsole1.
| Device ID | K162670 |
| 510k Number | K162670 |
| Device Name: | RSM 1824C With RConsole1 |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | DRTECH CORPORATION SUITE NO.2, 3 FLOOR, 29, DUNCHON-DAERO541BEON-GIL, JUNGWON-GU Seongnam-si, KR 13230 |
| Contact | Choul-woo Shin |
| Correspondent | Choul-woo Shin DRTECH CORPORATION SUITE NO.2, 3 FLOOR, 29, DUNCHON-DAERO541BEON-GIL, JUNGWON-GU Seongnam-si, KR 13230 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-26 |
| Decision Date | 2017-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800018411001 | K162670 | 000 |
| 08800018401606 | K162670 | 000 |