Accuro 3S
FDA 510(k) K253452 · Rivanna Medical, Inc.
510(k) numberK253452
Submission
- Device name
- Accuro 3S
- Applicant
- Rivanna Medical, Inc.
Charlottesville, VA, US - Received
- October 6, 2025
- Decision date
- July 24, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Sonic Incytes Medical Corp
| 510(k) | Device | Decision |
|---|---|---|
| K261014 | Accuro® 3S Needle Guide KitITX · Traditional | 07/24/2026SE |
| K254021 | Accuro XVIYO · Traditional | 04/09/2026SE |
| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | 06/13/2025SE |
| K243937 | Accuro 3SIYO · Traditional | 05/23/2025SE |
| K171594 | AccuroIYO · Traditional | 10/20/2017SE |
| K132736 | Accuro 3000 Ultrasound ScannerIYO · Traditional | 03/11/2014SE |
Questions and answers
When was Accuro 3S cleared by the FDA?
Accuro 3S (K253452) received a 510(k) decision of Substantially Equivalent on July 24, 2026, 291 days after the submission was received.
What is the product code of K253452?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.