Submission Details
| 510(k) Number | K241949 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 03, 2024 |
| Decision Date | January 17, 2025 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Digital Color Doppler Ultrasound System (P60 Series)
Jan 2025
Decision
198d
Days
Class 2
Risk
About This 510(k) Submission
K241949 is an FDA 510(k) clearance for the Digital Color Doppler Ultrasound System (P60 Series), a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Sonoscape Medical Corp. (Shenzhen, CN). The FDA issued a Cleared decision on January 17, 2025, 198 days after receiving the submission on July 3, 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
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