FDA 510(k)

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

K-Number: K170078 · 2017-05-17

Decision Date2017-05-17

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley is the device name listed in this FDA 510(k) record. The listed applicant is Medisono, LLC. It received FDA 510(k) clearance on 2017-05-17 under 510(k) number K170078. 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 Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley?

Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley is a medical device that received FDA 510(k) clearance on 2017-05-17. The listed applicant is Medisono, LLC. The 510(k) number is K170078.

When did Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley receive FDA 510(k) clearance?

Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley received FDA 510(k) clearance on 2017-05-17, under 510(k) number K170078.

Who is the listed applicant for Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley?

The FDA 510(k) record lists Medisono, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley?

The FDA product code for Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley is IYN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06861309Placental Imaging TechniquesRECRUITING NCT07012655Color Doppler Ultrasonography Evaluation of Abdominal and Peripheral Vasculopathy in Systemic Sclerosis PatientsCOMPLETED NCT07539727Clinical Value of Intestinal Ultrasound in Predicting Clinical Relapse in Crohn's Disease Patients in Deep Remission: a Multicenter Prospective Observational StudyRECRUITING

Other records listing Medisono, LLC as applicant

K231659MS55 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)K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10

Related Devices (Code: IYN)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.