Submission Details
| 510(k) Number | K250024 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 06, 2025 |
| Decision Date | May 30, 2025 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
TE Air Diagnostic Ultrasound System
May 2025
Decision
144d
Days
Class 2
Risk
About This 510(k) Submission
K250024 is an FDA 510(k) clearance for the TE Air 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 May 30, 2025, 144 days after receiving the submission on January 6, 2025. 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
Jufang Shi
154 submissions
154 cleared
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