# K170841: BiopSee, Mobile US

- Pathway: 510(k) (Traditional)
- Applicant: Medcom GmbH
- Decided: Jul 26, 2017 after 127 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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). 258 ancestors in all.
No later device cites it as a predicate yet.
1 of 259 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052379: Mim 3.5 (Circa), Mimvista Corp. (2005) Summary page 5.
- K153073: UroNav (Version 2.0), Invivo Corporation (2015) Summary page 5.
- K163119: NaviSuite SSI Edition, Medcom GmbH (2017). Cleared while this submission was under review Summary page 5.
- K112420: Oncentra Prostate 4.0, Nucletron (2011) Summary page 5.

## Indications for use
The BiopSee bundled system is a combination of MobileUS providing the “Medical Image Processing Workstation” which acquires and displays ultrasound images from external ultrasound scanners and the BiopSee “Image Fusion Navigation Software” which is a stereotaxic accessory for Ultrasound (US) devices. The BiopSee system is intended to be used in clinical interventions and for anatomical structures in a clinical setting where US imaging is currently used for visualizing such procedures. It displays the simulated image of a tracked insertion tool such as a biopsy needle on a computer monitor that shows images of the target organs and the current and the projected future path of the interventional instrument. The patient population is mainly people who need prostate biopsy. It is intended to be used mainly in the Urological departments for prostate biopsies. The BiopSee system is not intended to be used as a standalone diagnostic image device, since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always be seen as an additional source of information. The BiopSee system when connected with an electromagnetic tracker should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment. BiopSee is a prescription device.

Source page: https://510kreport.com/device/K170841
Methodology: https://510kreport.com/methodology