The following data is part of a premarket notification filed by Mcube Technology Co., Ltd. with the FDA for Cubescan Biocon-500 Diagnostic Ultrasound System.
| Device ID | K091518 |
| 510k Number | K091518 |
| Device Name: | CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MCUBE TECHNOLOGY CO., LTD. 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Contact | Charlie Mack |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-05-22 |
| Decision Date | 2009-06-18 |
| Summary: | summary |