# K171767: Cianna Medical SAVI Scout Reflector and SAVI Scout System

- Pathway: 510(k) (Traditional)
- Applicant: Cianna Medical, Inc.
- Decided: Oct 31, 2017 after 139 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K181692: 5cm Tag Applicator, 7cm Tag Applicator, 10 cm  Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) (2018), 2 descendants of its own
- K190932: RFID Localization System (2019), 1 descendant of its own
- K193189: RFID Localization System (2020), 0 descendants of its own

## Indications for use
The SAVI Scout Reflector is intended to be placed percutaneously in breast tissue to mark (>30 days) a biopsy site or a lumpectomy 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 breast biopsy site or a lumpectomy site intended for surgical removal.

Source page: https://510kreport.com/device/K171767
Methodology: https://510kreport.com/methodology