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 |