510(k) · Cleared
Recalled · 2011Modification to D-Spect Cardiac Scanner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Dynamics, Ltd. · KPS System, Tomography, Computed, Emission
Cleared on Oct 1, 2007 as substantially equivalent to K062450 (Spectrum Dynamics, Ltd., 2006) and 2 other predicates after a 27-day review. Its family tree reaches back 4 generations to 1994. 10 later devices descend from it. It has been recalled once.
- Decided
- Oct 1, 2007
- Review
- 27 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K943574 (1994). 22 ancestors in all, the oldest K885054 (1989). 10 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 3 generations backK021416 Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 2 generations backK040053 Precision VPS Impression MaterialDiscus Dental, Inc. · 2004
- 1 generation backK062450 D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2006
- This deviceK072468 Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007
- Descendant · cites it directly · 9 of its ownK110507 Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011
- Descendant · 2 generations on · 5 of its ownK161740 D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016
- Descendant · 3 generations on · 4 of its ownK180514 Veriton NMSpectrum Dynamics Medical, Ltd. · 2018
- Descendant · 4 generations on · 3 of its ownK182484 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018
- Descendant · 5 generations on · 2 of its ownK190457 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011 · cites it directly9descendants
- K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016 · 2 generations on5descendants
- K180514Veriton NMSpectrum Dynamics Medical, Ltd. · 2018 · 3 generations on4descendants
- K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018 · 4 generations on3descendants
- K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −3 | K021416 | Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −2 | K040053 | Precision VPS Impression Material | Discus Dental, Inc. | 2004 | — |
| −1 | K062450 | D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2006 | — |
| 0 (this device) | K072468 | Modification to D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2007 | — |
| +1 | K110507 | Cardiac Scanner and Processing System | Spectrum Dynamics (Israel), Ltd. | 2011 | — |
| +2 | K161740 | D-SPECT Scanner, D-SPECT L Scanner | Spectrum Dynamics Medical, Ltd. | 2016 | — |
| +3 | K180514 | Veriton NM | Spectrum Dynamics Medical, Ltd. | 2018 | — |
| +4 | K182484 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2018 | — |
| +5 | K190457 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2019 | — |
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 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K062450 | D-Spect Cardiac Scanner SystemSummary page 2…: Device Manufacturer 510(k) No. D-Spect TM Cardiac Scanner System Spectrum Dynamics Ltd. K062450 ADAC AutoQuant ADAC K980715 ADAC JETStream Workspace… | 2006 |
| * | K980715 | Autoquant Quantitative Perfusion Spect (QPS) & Quantitative Gated Spect (QGS)Summary page 2…) No. D-Spect TM Cardiac Scanner System Spectrum Dynamics Ltd. K062450 ADAC AutoQuant ADAC K980715 ADAC JETStream Workspace ADAC K061029 4. Intended Use The D-SpectTM is an em… | 1998 |
| * | K061029 | Jetstream WorkspaceSummary page 2…62450 ADAC AutoQuant ADAC K980715 ADAC JETStream Workspace ADAC K061029 4. Intended Use The D-SpectTM is an emission computed tomography system intended to detect the location and distribution of… | 2006 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110507 | Cardiac Scanner and Processing System | 2011 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2011 | Not classified | Z-1214-2012 | Nonconforming Material/Component | 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 housing may pull away from its secured… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 22 ancestors have a recall of any class.
- Of its descendants, K110507 (Spectrum Dynamics (Israel), Ltd., 2011) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K062450.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072468 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072468: Modification to D-Spect Cardiac Scanner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072468
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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