# K200899: Quantib AI Node

- Pathway: 510(k) (Traditional)
- Applicant: Quantib B.V.
- Decided: Jun 15, 2020 after 73 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: 14 generations back to K913770 (1991). 187 ancestors in all.
No later device cites it as a predicate yet.
3 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183272: AI Rad Companion (Engine), Siemens Medical Solutions USA, Inc. (2019) Summary page 4.
- K162025: IntelliSpace Portal Platform, Philips Medical Systems Nederlands B.V. (2016) Summary page 4.

## Indications for use
Quantib AI Node is a software platform that provides visualization and annotation tools and enables external post-processing extensions for medical images. The software platform is designed to support in qualitative and quantitative measurement, analysis, and reporting of clinical data. The software platform provides means for storing of data and transferring data from and into other systems such as PACS. The software platform provides an interface to integrate processing extensions and custom input/output modules. Quantib AI Node functionality includes: • Interface for multi-modality and multi-vendor input/output of data, such as DICOM data • Initiation of extensions to process the data based on properties of the data • Interface for extensions that provide custom data import/output, post-processing, and user interface functionality • User interface for visualization and annotation of medical images, and for correction and confirmation of results generated by post-processing extensions Quantib AI Node is intended to be used by trained medical professionals.

Source page: https://510kreport.com/device/K200899
Methodology: https://510kreport.com/methodology