# K033254: Forte Gamma Camera System

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Oct 22, 2003 after 14 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 4 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K982911 (1998). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
4 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982911: FORTE, Adac Laboratories (1998) Summary page 1.

## Most influential descendants
- K062298: Apollo Gamma Camera System (2006), 2 descendants of its own
- K080927: Brightview VCT Imaging System (2008), 1 descendant of its own
- K083649: Cardius 3 X-Act (2009), 0 descendants of its own

## Recalls of this device
- Sep 19, 2019 · Class I · Z-0214-2020: An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
- Sep 19, 2019 · Class I · Z-0217-2020: An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
- Sep 19, 2019 · Class I · Z-0215-2020: An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
- Mar 6, 2015 · Class II · Z-1777-2015: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overh

## Indications for use
The ForteTMGamma Camera 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/K033254
Methodology: https://510kreport.com/methodology