The following data is part of a premarket notification filed by Imfou Co., Ltd with the FDA for Feel-drcs.
| Device ID | K110033 |
| 510k Number | K110033 |
| Device Name: | FEEL-DRCS |
| Classification | System, Image Processing, Radiological |
| Applicant | IMFOU CO., LTD #821 SAMIL PLAZA, 837-26 YEUKSAM-DONG Gangnam-gu, Seoul, KR 135-768 |
| Contact | Ho Dong Yang |
| Correspondent | Ho Dong Yang IMFOU CO., LTD #821 SAMIL PLAZA, 837-26 YEUKSAM-DONG Gangnam-gu, Seoul, KR 135-768 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-05 |
| Decision Date | 2011-09-15 |
| Summary: | summary |