# K183400: EnVisio Navigation Sytem

- Pathway: 510(k) (Traditional)
- Applicant: Elucent Medical, Inc.
- Decided: Mar 22, 2019 after 105 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K181007 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181007: Cianna Medical SAVI Scout Reflector and SAVI Scout System, Cianna Medical, Inc. (2018) Summary page 4.

## Recalls of this device
- Nov 18, 2024 · Class II · Z-0806-2025: There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVis

## Indications for use
The SmartClip Soft Tissue Marker is intended to be placed percutaneously in soft tissue to permanently mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (EnVisio Navigation System); the SmartClip is located and surgically removed with the target tissue. The EnVisio Navigation System is intended only for the non-imaging detection and localization (by navigation) of the SmartClip that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

Source page: https://510kreport.com/device/K183400
Methodology: https://510kreport.com/methodology