# K013496: Modification to Skylight Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Nov 6, 2001 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: 1 generation back to K000908 (2000). 1 ancestor in all.
3 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)
- K000908: Skylight Imaging System, Adac Laboratories (2000) Summary page 1.

## Most influential descendants
- K031705: Skylight Imaging System (2003), 2 descendants of its own
- 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 distribution of single photon and positron emitting radioisotopes within the body for interpretation by medical personnel.

Source page: https://510kreport.com/device/K013496
Methodology: https://510kreport.com/methodology