K091941 is an FDA 510(k) clearance for the DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Nanshan, Shenzhen, CN). The FDA issued a Cleared decision on July 9, 2009, 9 days after receiving the submission on June 30, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K091941 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2009 |
| Decision Date | July 09, 2009 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | ITX — Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |