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FDA 510(k)

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10

K-Number: K163688 · 2017-02-23

ApplicantMedisono, LLC
Decision Date2017-02-23
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 is a medical device manufactured by Medisono, LLC. It received FDA 510(k) clearance on 2017-02-23 under approval number K163688. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10?

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 is a medical device that received FDA 510(k) clearance on 2017-02-23. It is manufactured by Medisono, LLC. The 510(k) number is K163688.

When was Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 approved by the FDA?

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 received FDA 510(k) clearance on 2017-02-23, under approval number K163688.

What company makes Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10?

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 is manufactured by Medisono, LLC.

What is the FDA product code for Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10?

The FDA product code for Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 is IYN.

Related Clinical Trials

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Related PubMed Literature

PMID: 42207283 [Legal responsibility in AI-assisted radiological reporting]. Radiologie (Heidelberg, Germany) (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41385025 AI medical device post-market surveillance regulations: consensus recommendations by the European Society of Radiology. Insights into imaging (2025) PMID: 41271017 Lymphedema Imaging and AI: A Review of Diagnostic Modalities, Biomarkers, and Clinical Integration. Biomedical journal (2025)

Other Devices by Medisono, LLC

K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley

Related Devices (Code: IYN)

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Official Source

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