# K121023: Spectrum V.0

- Pathway: 510(k) (Traditional)
- Applicant: Intrinsic Medical Imaging
- Decided: May 31, 2012 after 57 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: 10 generations back to K913770 (1991). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071331: Vitrea Version 4.0, Vital Images, Inc. (2007) Summary page 2.

## Indications for use
The IMI Spectrum V.0 is a medical diagnostic system that allows the processing, review, and analysis of multi-dimensional digital images acquired from CT imaging devices. The IMI Spectrum V.0 is not meant for primary image interpretation in mammography. The IMI Spectrum V.0 is intended to receive patient specific data sets of CT images and can be used for: * 3D presentation of complex anatomical relationships and specified structures with the complete data set; * System generation of a 3D model of the desired anatomical structure; * Viewing of the volume rendered and Multiplanar Reconstruction (MPR) representations of the desired anatomical structure providing additional supplemental information to support interpretation and treatment planning; * Viewing the inner and outer surfaces of organs as well as within their wall providing additional supplemental information to support interpretation and treatment planning; * Planning and following a navigation path through the desired anatomical structure; * Programmed and interactive navigation and flythrough within the 3D volume including specified organs and structures; * Measurement of position and length of anatomical structures within the 3D volume; and * Common core technology with specialized interfaces for different anatomical structures.

Source page: https://510kreport.com/device/K121023
Methodology: https://510kreport.com/methodology