# K121292: Dynapbv Body Software

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 30, 2012 after 91 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: 5 generations back to K954355 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011447: IN Space 3D, Siemens Medical Solutions USA, Inc. (2001) Summary page 1.
- K111052: Syngo Neuro PBV-IR, Siemens Medical Solutions USA, Inc. (2011) Summary page 2.

## Indications for use
syngo DynaPBV Body is an extended software application to the InSpace 3D software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. syngo DynaPBV Body is intended for imaging primarily soft tissue for diagnosis, surgical planning, interventional procedures and treatment follow-up. It is design for the visualization of contrast enhanced blood distribution in the body using color coded relative values for diagnosis., This software is designed to visually assist physicians in the diagnosis and treatment of vessel malformations (i.e. Aneurysms, AVMV's and Stenoses)

Source page: https://510kreport.com/device/K121292
Methodology: https://510kreport.com/methodology