# K062450: D-Spect Cardiac Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Dynamics, Ltd.
- Decided: Oct 20, 2006 after 59 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: 3 generations back to K943574 (1994). 16 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031825: C.CAM, Danish Diagnostic Development A/S (2003) Summary page 2.
- K053062: Cardiarc Spect Imaging Device, Model CQ103-RV2, Cardiarc, Ltd. (2006) Summary page 2.
- K040053: Precision VPS Impression Material, Discus Dental, Inc. (2004) Summary page 2.
- DEN040007: Implantable Radio Frequency Transponder System. Our reading of the summary gave K033440, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040007, Implantable Radio Frequency Transponder System (), granted —; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- (no number) SmartBand: named in the summary without a submission number

## Most influential descendants
- K072468: Modification to D-Spect Cardiac Scanner System (2007), 10 descendants of its own
- 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

## 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/K062450
Methodology: https://510kreport.com/methodology