K181637 is an FDA 510(k) clearance for the DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 9, 2019, 202 days after receiving the submission on June 21, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K181637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2018 |
| Decision Date | January 09, 2019 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |