The following data is part of a premarket notification filed by Coreline Soft Co., Ltd. with the FDA for A View Lcs.
| Device ID | K201710 |
| 510k Number | K201710 |
| Device Name: | A View LCS |
| 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 | Hye Yi Park |
| Correspondent | Hye Yi 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 | 2020-06-23 |
| Decision Date | 2020-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800025300084 | K201710 | 000 |