# K973233: Image Fusion and Review System

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Nov 25, 1997 after 89 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ADAC Pinnacle® Apex: named in the summary without a submission number

## Most influential descendants
- K083591: Ikoengelo, Version 2 (2008), 19 descendants of its own
- K111311: Segmentation Assistant for Prostate-Auto Contouring (2011), 9 descendants of its own
- K132944: Advantagesim MD MR Pelvic Organ at Risk Segmentation (2014), 7 descendants of its own
- K151233: Monaco (2015), 6 descendants of its own
- K183037: Monaco RTP System (2018), 5 descendants of its own

## Indications for use
The Image Fusion and Review System is intended to register images geometrically in 3D and display sets of different types of medical images such as, MCD, SPECT, PET, CT, and MRI, as composite images. It allows the operator to rotate, translate, and align images anatomically, and match the geometric position of the images relative to each other.

Source page: https://510kreport.com/device/K973233
Methodology: https://510kreport.com/methodology