# K031705: Skylight Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Jun 17, 2003 after 15 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
Longest line of descent: 2 generations back to K000908 (2000). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013496: Modification to Skylight Imaging System, Adac Laboratories (2001)

## Most influential descendants
- K041218: Griffin Spect/CT Imaging System (2004), 1 descendant of its own
- K051351: Precedence Spect/CT Imaging System (2005), 0 descendants of its own

## Indications for use
The Skylight Imaging System is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

Source page: https://510kreport.com/device/K031705
Methodology: https://510kreport.com/methodology