Submission Details
| 510(k) Number | K230768 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 20, 2023 |
| Decision Date | June 09, 2023 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
Jun 2023
Decision
81d
Days
Class 2
Risk
About This 510(k) Submission
K230768 is an FDA 510(k) clearance for the M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium 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 June 9, 2023, 81 days after receiving the submission on March 20, 2023. 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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