# K961849: The Roboguide

- Pathway: 510(k) (Traditional)
- Applicant: Shai Syg Motion and Innovations, Ltd.
- Decided: Aug 21, 1996 after 100 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cytoguide: named in the summary without a submission number
- (no number) Mammoguide: named in the summary without a submission number

## Indications for use
The ROBOGUIDE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions.

Source page: https://510kreport.com/device/K961849
Methodology: https://510kreport.com/methodology