Submission Details
| 510(k) Number | K253487 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 21, 2025 |
| Decision Date | November 17, 2025 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System
Nov 2025
Decision
27d
Days
Class 2
Risk
About This 510(k) Submission
K253487 is an FDA 510(k) clearance for the ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Siemens Medical Solutions USA, Inc. (Issaquah, US). The FDA issued a Cleared decision on November 17, 2025, 27 days after receiving the submission on October 21, 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
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