# K181007: Cianna Medical SAVI Scout Reflector and SAVI Scout System

- Pathway: 510(k) (Traditional)
- Applicant: Cianna Medical, Inc.
- Decided: Aug 2, 2018 after 107 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K210600: MOLLI (2021), 5 descendants of its own
- K223107: MOLLI 2 (2023), 4 descendants of its own
- K231579: MOLLI 2 (2023), 3 descendants of its own
- K240042: MOLLI 2 System (2024), 1 descendant of its own
- K231468: SCOUT MD Surgical Guidance System (2024), 1 descendant of its own

## Indications for use
The SAVI Scout Reflector is intended to be placed percutaneously in soft tissue to mark (>30 days) 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 (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector 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/K181007
Methodology: https://510kreport.com/methodology