# K161507: Cianna Medical SAVI Scout Reflector and SAVI Scout System

- Pathway: 510(k) (Traditional)
- Applicant: Cianna Medical, Inc.
- Decided: Jul 29, 2016 after 58 days
- Product code: PDW (Internal Tissue Marker)
- Device class: 2
- Regulation: 21 CFR 878.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K163667: RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) (2017), 0 descendants of its own

## Indications for use
The SAVI Scout Reflector is intended to be placed percutaneously in the breast to temporarily mark (<30days) a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound 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 lumpectomy site intended for surgical removal.

Source page: https://510kreport.com/device/K161507
Methodology: https://510kreport.com/methodology