Dolphin Medical Imaging USB Ultrasound System
FDA 510(k) K192573 · Dolphin Medical Imaging, LLC
510(k) numberK192573
Submission
- Device name
- Dolphin Medical Imaging USB Ultrasound System
- Applicant
- Dolphin Medical Imaging, LLC
Folsom, CA, US - Received
- September 18, 2019
- Decision date
- November 19, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| 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 |
Questions and answers
When was Dolphin Medical Imaging USB Ultrasound System cleared by the FDA?
Dolphin Medical Imaging USB Ultrasound System (K192573) received a 510(k) decision of Substantially Equivalent on November 19, 2019, 62 days after the submission was received.
What is the product code of K192573?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.