The following data is part of a premarket notification filed by Drtech Corporation with the FDA for Rsm 2430c.
| Device ID | K170930 |
| 510k Number | K170930 |
| Device Name: | RSM 2430C |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| 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 | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-29 |
| Decision Date | 2017-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800018401903 | K170930 | 000 |