The following data is part of a premarket notification filed by Coreline Soft Co., Ltd with the FDA for Aview Modeler.
| Device ID | K192040 |
| 510k Number | K192040 |
| Device Name: | AVIEW Modeler |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-31 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800025300022 | K192040 | 000 |