# K173138: Biim Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Biim Ultrasound AS
- Decided: Oct 27, 2017 after 28 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K935595 (1995). 212 ancestors in all.
No later device cites it as a predicate yet.
6 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163138: Clarius Ultrasound System, Clarius Mobile Health Corp. (2016) Summary page 6.

## Indications for 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)

Source page: https://510kreport.com/device/K173138
Methodology: https://510kreport.com/methodology