# Medisono, LLC

- Location (FDA's records): Wilmington, DE
- FDA decisions: 3 (2017–2024): 3 510(k) clearances
- Names in FDA's records: Medisono, LLC (2); Medisono (1)
- Product codes: IYN (3)
- 510(k) review time since 2016: median 128 days, against 83 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 13 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sonoscape Company Limited: 6 (https://510kreport.com/company/sonoscape)
- Sonoscape Medical Corp.: 3 (https://510kreport.com/company/sonoscape-medical)
- Edan Instruments, Inc.: 3 (https://510kreport.com/company/edan-instruments)
- Chison Medical Imaging Co., Ltd.: 1 (https://510kreport.com/company/chison-medical-imaging)

## Recent decisions
- K231659: MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus) (Feb 15, 2024)
- K170078: Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley (May 17, 2017)
- K163688: Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 (Feb 23, 2017)

Source page: https://510kreport.com/company/medisono