# K033001: Apex Detector Electronics & Acquisition Interface, Model XL-4

- Pathway: 510(k) (Traditional)
- Applicant: Transphoton Corporation
- Decided: Dec 24, 2003 after 90 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 K013353 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021823: Cardiospect D90/Cardio Cam, Nuclear Cardiology Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K070589: C! (2007), 0 descendants of its own

## Indications for use
The Apex XL-4 is intended for use as an acquisition of Nuclear Medicine SPECT and Planar Gamma Camera images.

Source page: https://510kreport.com/device/K033001
Methodology: https://510kreport.com/methodology