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510(k) Data Aggregation
K Number
K173138Device Name
Biim Diagnostic Ultrasound System
Manufacturer
Date Cleared
2017-10-27
(28 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
Biim Ultrasound AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Biim™ Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:
- · Musculo-skeletal (conventional and superficial)
- Needle guidance
- · Pediatric
- · Peripheral Vessel
- · Small Organ (breast, thyroid, parathyroid, testicles)
Device Description
The Biim Diagnostic Ultrasound System is a portable, general-purpose, software-controlled sonography system based on a digital architecture used to acquire and display high-resolution, real-time ultrasound data through a commercial off-the-shelf iOS or Android device. The Biim Diagnostic Ultrasound System supports wireless transducer connectivity of the ultrasound images to the display device.
The Biim Diagnostic Ultrasound System consists of:
A commercial off-the-shelf iOS or Android display device
Biim Ultrasound software running as an app on the display device
The wireless Biim linear array transducer with Biim Ultrasound firmware.
Lithium-Ion rechargeable battery
Battery charger
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