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FDA 510(k)

Biim Diagnostic Ultrasound System

K-Number: K173138 · 2017-10-27

ApplicantBiim Ultrasound AS
Decision Date2017-10-27
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Biim Diagnostic Ultrasound System is a medical device manufactured by Biim Ultrasound AS. It received FDA 510(k) clearance on 2017-10-27 under approval number K173138. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biim Diagnostic Ultrasound System?

Biim Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-10-27. It is manufactured by Biim Ultrasound AS. The 510(k) number is K173138.

When was Biim Diagnostic Ultrasound System approved by the FDA?

Biim Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-10-27, under approval number K173138.

What company makes Biim Diagnostic Ultrasound System?

Biim Diagnostic Ultrasound System is manufactured by Biim Ultrasound AS.

What is the FDA product code for Biim Diagnostic Ultrasound System?

The FDA product code for Biim Diagnostic Ultrasound System is IYO.

Related Clinical Trials

NCT07040696 Accuracy of Venous Excess Ultrasound Score at Hospital Admission to Predict Acute Kidney Injury COMPLETED NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT05857852 Low-Intensity Focused Ultrasound for Cocaine Use Disorder COMPLETED NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07608614 Sleep and Performance RECRUITING

Related PubMed Literature

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: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Related Devices (Code: IYO)

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Official Source

View on FDA Database →

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

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