Submission Details
| 510(k) Number | K241432 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 21, 2024 |
| Decision Date | September 12, 2024 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
Sep 2024
Decision
114d
Days
Class 2
Risk
About This 510(k) Submission
K241432 is an FDA 510(k) clearance for the MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System, 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 September 12, 2024, 114 days after receiving the submission on May 21, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.
Device Classification
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1550 |
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Shenzhen · CN
Tang Jing
154 submissions
154 cleared
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