The following data is part of a premarket notification filed by Coreline Soft Co.,ltd with the FDA for Aview Rt Acs.
| Device ID | K220408 |
| 510k Number | K220408 |
| Device Name: | AVIEW RT ACS |
| Classification | Radiological Image Processing Software For Radiation Therapy |
| Applicant | Coreline Soft Co.,Ltd 4,5F (Yeonnam-dong), 49, World Cup Buk-ro-6-gil, Mapo-gu Seoul, KR 03991 |
| Contact | Hyeyi Park |
| Correspondent | Hyeyi Park Coreline Soft Co.,Ltd 4,5F (Yeonnam-dong), 49, World Cup Buk-ro-6-gil, Mapo-gu Seoul, KR 03991 |
| Product Code | QKB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-14 |
| Decision Date | 2022-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800025300145 | K220408 | 000 |