The following data is part of a premarket notification filed by Mcube Technology Co., Ltd. with the FDA for Cubescan / Biocon-700.
| Device ID | K111021 |
| 510k Number | K111021 |
| Device Name: | CUBESCAN / BIOCON-700 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | MCUBE TECHNOLOGY CO., LTD. 803 SHINNAE-TECHNOTOWN 485 SANGBONG-DONG Chungnang-ku, Seoul, KR 131-220 |
| Contact | Seungtai Kim |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-04-12 |
| Decision Date | 2011-04-27 |
| Summary: | summary |