# K061418: Quantiva

- Pathway: 510(k) (Traditional)
- Applicant: Tomographix IP, Ltd.
- Decided: Jul 21, 2006 after 60 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: 7 generations back to K954678 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033955: RTIST, Mirada Solutions, Ltd. (2004) Summary page 1.

## Indications for use
The QuantivaTM is a software application intended to co-register and display 2D & 3D multimodality (CT & PET) medical images data. The medical practitioner can visualize, process, render, view, store, print and distribute DICOM 3.0 compliant medical image data within the system and/or across computer networks as distributed locations utilizing standard P.C. hardware. The volume and linear measurement functions are intended for evaluation and quantification of tumor measurements, location/displacement study, analysis and evaluation of both hard and soft tissue. The software also supports interactive segmentation of the region of interest, automated contouring of multi-slice ROL and labeling of avoidance structures during evaluation. Typical users of Quantiva TM are for trained professionals (including but not limited to: radiologists, clinicians and technicians). When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. The Quantiva TM is indicated for use when it is necessary to acquire, record, review and distribute these images. The Quantiva TM is a prescription device. The labeling, instructions and user operations are designed for trained, licensed medical professionals.

Source page: https://510kreport.com/device/K061418
Methodology: https://510kreport.com/methodology