510(k) · Cleared
ClearedCardiac Scanner and Processing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Dynamics (Israel), Ltd. · KPS System, Tomography, Computed, Emission
Cleared on Jul 13, 2011 as substantially equivalent to K072468 (Spectrum Dynamics, Ltd., 2007) and 3 other predicates after a 141-day review. Its family tree reaches back 5 generations to 1994. 9 later devices descend from it.
- Decided
- Jul 13, 2011
- Review
- 141 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K943574 (1994). 29 ancestors in all, the oldest K885054 (1989). 9 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 4 generations backK021416 Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 3 generations backK040053 Precision VPS Impression MaterialDiscus Dental, Inc. · 2004
- 2 generations backK062450 D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2006
- 1 generation backK072468 Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · Recalled
- This deviceK110507 Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011
- Descendant · cites it directly · 5 of its ownK161740 D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016
- Descendant · 2 generations on · 4 of its ownK180514 Veriton NMSpectrum Dynamics Medical, Ltd. · 2018
- Descendant · 3 generations on · 3 of its ownK182484 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018
- Descendant · 4 generations on · 2 of its ownK190457 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK160120 D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd. · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016 · cites it directly5descendants
- K180514Veriton NMSpectrum Dynamics Medical, Ltd. · 2018 · 2 generations on4descendants
- K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018 · 3 generations on3descendants
- K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019 · 4 generations on2descendants
- K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd. · 2016 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −4 | K021416 | Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −3 | K040053 | Precision VPS Impression Material | Discus Dental, Inc. | 2004 | — |
| −2 | K062450 | D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2006 | — |
| −1 | K072468 | Modification to D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2007 | 1 |
| 0 (this device) | K110507 | Cardiac Scanner and Processing System | Spectrum Dynamics (Israel), Ltd. | 2011 | — |
| +1 | K161740 | D-SPECT Scanner, D-SPECT L Scanner | Spectrum Dynamics Medical, Ltd. | 2016 | — |
| +2 | K180514 | Veriton NM | Spectrum Dynamics Medical, Ltd. | 2018 | — |
| +3 | K182484 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2018 | — |
| +4 | K190457 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2019 | — |
| +1 | K160120 | D-SPECT Processing and Reviewing Workstation | Spectrum Dynamics, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072468 | Modification to D-Spect Cardiac Scanner SystemSummary page 2…use and indications of the submitted modified D-SPECTTM Cardiac Scanner is identical to the legally marked devices: Spectrum Dynamics: D-SPECTTh Cardiac Scanner System (K072468), ELGEMS: eNTEGRA workstation (1(003264), ADAC Laboratories: AutoQUANT (K9807 15) and UltraSPECT: V/rBR Half Dose (1(080784). Sim… | 2007 |
| * | K003264 | QPS/BPGS/Moco Processing Applications for Entegra WorkstationSummary page 1…edicate Devices Spectrum Dynamics: D-SPECPm Cardiac Scanner System - K(072468 ELGEMS: eNTEGRA workstation - K003264 ADAC Laboratories: AutoQUANT - K(980715 UltraSPECT: WBR Half Dose -… | 2000 |
| * | K980715 | Autoquant Quantitative Perfusion Spect (QPS) & Quantitative Gated Spect (QGS)Summary page 2…tical to the legally marked devices: Spectrum Dynamics: D-SPECTTh Cardiac Scanner System (K072468), ELGEMS: eNTEGRA workstation (1(003264), ADAC Laboratories: AutoQUANT (K9807 15) and UltraSPECT: V/rBR Half Dose (1(080784). Similarity of intended use, indications and technological features demonstrated, the… | 1998 |
| * | K080784 | WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneSummary page 1…K003264 ADAC Laboratories: AutoQUANT - K(980715 UltraSPECT: WBR Half Dose - K080784 Device Description Spectrum Dynamics' D-SPECT Cardiac Scanner System is a SPECT device, which is designed to perform myoc… | 2008 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 7 of the 29 ancestors have a recall of any class.
- Of its descendants, K161740 (Spectrum Dynamics Medical, Ltd., 2016) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
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…
Read the full statement (163 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110507: Cardiac Scanner and Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110507
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026