Accuro
FDA 510(k) K171594 · Rivanna Medical, LLC
510(k) numberK171594
Submission
- Device name
- Accuro
- Applicant
- Rivanna Medical, LLC
Charlottesville, VA, US - Received
- May 31, 2017
- Decision date
- October 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IYO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253452 | Accuro 3SIYO · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| K260190 | ArthurIYO · Traditional | ROPCA ApS | 06/18/2026SE |
| K252237 | EdgeFlow UW20IYO · Traditional | Edgecare, Inc. | 04/17/2026SE |
| K254021 | Accuro XVIYO · Traditional | Rivanna Medical, Inc. | 04/09/2026SE |
| K253898 | QT Scanner 2000 Model AIYO · Special | QT Imaging Holdings, Inc. | 03/04/2026SE |
| K253714 | IntraSight PlusIYO · Traditional | Philips Image Guided Therapy Corporation | 02/24/2026SE |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)IYO · Traditional | Eieling Technology (Shenzhen) Limited | 02/06/2026SE |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro)IYO · Traditional | Astrasono Technology Co., Ltd. | 09/30/2025SE |
| K250381 | Deepsight NeedleVue LC1 Ultrasound SystemIYO · Traditional | DeepSight Technology, Inc. | 08/01/2025SE |
| K243227 | B-ScanIYO · Traditional | Accutome, Inc. Doing Business AS Keeler USA | 07/11/2025SE |
More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K261014 | Accuro® 3S Needle Guide KitITX · Traditional | 07/24/2026SE |
| K253452 | Accuro 3SIYO · 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 |
| K132736 | Accuro 3000 Ultrasound ScannerIYO · Traditional | 03/11/2014SE |
Questions and answers
When was Accuro cleared by the FDA?
Accuro (K171594) received a 510(k) decision of Substantially Equivalent on October 20, 2017, 142 days after the submission was received.
What is the product code of K171594?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.