# K042646: Dynact

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Oct 19, 2004 after 21 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
72 later devices descend from it; 4 cite it directly.
0 of 73 devices 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) In Space 3D software package: named in the summary without a submission number
- (no number) Siremobile 3D software: named in the summary without a submission number

## Most influential descendants
- K060749: Xperct (2006), 53 descendants of its own
- K062650: EP Navigator Software (2006), 49 descendants of its own
- K101311: EP Navigator R3 (2010), 41 descendants of its own
- K111245: Heartnavigator Release 1 (2011), 39 descendants of its own
- K121781: Echonavigator Release 1 (2012), 32 descendants of its own

## Indications for use
DynaCT is an x-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

Source page: https://510kreport.com/device/K042646
Methodology: https://510kreport.com/methodology