# K982911: FORTE

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Nov 16, 1998 after 90 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
4 of 6 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) Siemens E.CAM Profile AC: named in the summary without a submission number
- (no number) Millennium MT & MG: named in the summary without a submission number

## Most influential descendants
- K033254: Forte Gamma Camera System (2003), 3 descendants of its own
- 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
- K991535: Convergence CDR for Hitachi Spectradigital V250DSP Gamma Cameras (1999), 0 descendants of its own

## Recalls of this device
- Sep 19, 2019 · Class I · Z-0213-2020: 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-0216-2020: 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-1774-2015: 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
Vertex Ultra is intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

Source page: https://510kreport.com/device/K982911
Methodology: https://510kreport.com/methodology