# K072468: Modification to D-Spect Cardiac Scanner System

- Pathway: 510(k) (Special)
- Applicant: Spectrum Dynamics, Ltd.
- Decided: Oct 1, 2007 after 27 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K943574 (1994). 22 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062450: D-Spect Cardiac Scanner System, Spectrum Dynamics, Ltd. (2006) Summary page 2.
- K980715: Autoquant Quantitative Perfusion Spect (QPS) & Quantitative Gated Spect (QGS), Adac Laboratories (1998) Summary page 2.
- K061029: Jetstream Workspace, Adac Laboratories (2006) Summary page 2.

## Most influential descendants
- K110507: Cardiac Scanner and Processing System (2011), 9 descendants of its own
- K161740: D-SPECT Scanner, D-SPECT L Scanner (2016), 5 descendants of its own
- K180514: Veriton NM (2018), 4 descendants of its own
- K182484: VERITON CT whole body SPECT/CT system (2018), 3 descendants of its own
- K190457: VERITON CT whole body SPECT/CT system (2019), 2 descendants of its own

## Recalls of this device
- Jul 15, 2011 · Not classified · Z-1214-2012: The firm received a report related to the detector housing on the D-SPECT Cardiac Scanner. Specifically, it was reported that if the detector housing securing mechanism is compromised, the detector ho

## Indications for use
D-SPECT is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT is primarily intended for cardiac applications. D-SPECT supports radionuclides within the energy range of 40 -170 keV.

Source page: https://510kreport.com/device/K072468
Methodology: https://510kreport.com/methodology