# K111052: Syngo Neuro PBV-IR

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 20, 2011 after 35 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 K954355 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 2.

## Most influential descendants
- K121292: Dynapbv Body Software (2012), 0 descendants of its own

## Indications for use
Syngo Neuro-PBV IR is an extended software application to the InSpace 3D software option which allows the reconstruction of two-dimentional images acquired with a standard angiographic C-arm device into a three-dimentional image format. Syngo Neuro-PBV-IR 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 arterial and venous vessels in the head 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, AVM's and Stenoses)

Source page: https://510kreport.com/device/K111052
Methodology: https://510kreport.com/methodology