# K971717: Fly Through

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 3, 1997 after 117 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
228 later devices descend from it; 3 cite it directly.
1 of 229 devices in its family (counting itself) has 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) Advantage Windows 3D with Navigator: named in the summary without a submission number
- (no number) Prominence Workstation (Silhouette): named in the summary without a submission number

## Most influential descendants
- K030982: Syngo Colonography Software Package (2003), 227 descendants of its own
- K033102: Medic Colon Model, Release 1 (2003), 210 descendants of its own
- K042674: Colon Car 1.2 (2004), 209 descendants of its own
- K061214: Aquariusaps Server (2006), 134 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own

## Indications for use
From user specified sets of CT or MR images, Fly Through can be used for 3D presentation of segmented anatomic models (e.g., tracheas, bones, vessels, colon, etc.); navigating interactively through 3D segmented models that represent body cavities (e.g., vessels, colon, spine, lung, etc.); for viewing the inner surface of organ models (vessels, colon, etc.). Fly Through offers advantages over real endoscopy. For example, Fly Through can be performed within models of organs or blood vessels inaccessible to a real endoscope; a training tool for surgeons to practice endoscopic procedures; surgical planning; feasibility study of an actual endoscopic procedure; and a 3D positioning and orientation tool for Multiplanar reconstruction, thus assisting diagnosis from Multi-Planar-Reconstructions (MPRs): the Fly Through tool can help the user to position and visualize the 3-dimensional location of the MPR within the segmented dataset.

Source page: https://510kreport.com/device/K971717
Methodology: https://510kreport.com/methodology