K091518 is an FDA 510(k) clearance for the CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Mcube Technology Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on June 18, 2009, 27 days after receiving the submission on May 22, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K091518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2009 |
| Decision Date | June 18, 2009 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |