# K163048: Smart Stitching Software System, Image Processing, Radiological

- Pathway: 510(k) (Traditional)
- Applicant: Osko, Inc.
- Decided: Jul 28, 2017 after 269 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K904519 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022881: Cedara I-Softview, Cedara Software Corp. (2002) Summary page 4.

## Indications for use
Smart Stitching software is indicated for use to allow post-capture positioning and joining of individual images to produce an additional composite image for two dimensional image review.

Source page: https://510kreport.com/device/K163048
Methodology: https://510kreport.com/methodology