# K110507: Cardiac Scanner and Processing System

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Dynamics (Israel), Ltd.
- Decided: Jul 13, 2011 after 141 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: 5 generations back to K943574 (1994). 29 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072468: Modification to D-Spect Cardiac Scanner System, Spectrum Dynamics, Ltd. (2007) Summary page 2.
- K003264: QPS/BPGS/Moco Processing Applications for Entegra Workstation, Ge Medical Systems F.I. Haifa (2000) Summary page 1.
- K980715: Autoquant Quantitative Perfusion Spect (QPS) & Quantitative Gated Spect (QGS), Adac Laboratories (1998) Summary page 2.
- K080784: WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone, Ultraspect, Ltd. (2008) Summary page 1.

## Most influential descendants
- 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
- K160120: D-SPECT Processing and Reviewing Workstation (2016), 2 descendants of its own

## Indications for use
The D-SPECT Cardiac Scanner and System 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 D-SPECT Cardiac Scanner System includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT Cardiac Scanner System is primarily intended, but not limited to, cardiac applications. D-SPECT Cardiac Scanner System supports radionuclides within the energy range of 40-170 key. The D-SPECT Cardiac Scanner System supports acquisition and imaging modes such as, but not limited to, SPECT (Single Photon Emission Computed Tomography), Multi-Gated SPECT and features low count rate (low dose) acquisition, with no lose in image quality. D-SPECT Cardiac Scanner System is intended for Processing, Reporting, Archiving, Display, Communication and analysis of SPECT data, using tools for imaging and fuilly automated review and quantification of Cardiac SPECT data including Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS).

Source page: https://510kreport.com/device/K110507
Methodology: https://510kreport.com/methodology