# K163119: NaviSuite SSI Edition

- Pathway: 510(k) (Traditional)
- Applicant: Medcom GmbH
- Decided: May 1, 2017 after 174 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: 18 generations back to K935595 (1995). 239 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 241 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.
- K153277: 6200 Ultrasound System and 6250 Ultrasound System, Esaote, S.p.A. (2016) Summary page 5.

## Most influential descendants
- K170841: BiopSee, Mobile US (2017), 0 descendants of its own

## Indications for use
The NaviSuite SSI Edition is used to support a clinical ultra-sound session and follow percutaneous procedure by means of providing additional real-time image information from a 2nd modality like CT or MR or US or its combination with the possibility to plan the ideal treatment procedure. The second modality or their combinations are acquired and 3D is generated inside the software permitting the anatomical correlation with the patient position. "The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information." "The 2nd modality image only should not be used for diagnostic purposes."

Source page: https://510kreport.com/device/K163119
Methodology: https://510kreport.com/methodology