510(k) · Cleared
ClearedD-SPECT Processing and Reviewing Workstation
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 Mar 21, 2016 as substantially equivalent to K110507 (Spectrum Dynamics (Israel), Ltd., 2011) after a 62-day review. Its family tree reaches back 6 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 21, 2016
- Review
- 62 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K943574 (1994). 30 ancestors in all, the oldest K885054 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 5 generations backK021416 Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 4 generations backK040053 Precision VPS Impression MaterialDiscus Dental, Inc. · 2004
- 3 generations backK062450 D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2006
- 2 generations backK072468 Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · Recalled
- 1 generation backK110507 Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011
- This deviceK160120 D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK212230 TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK253532 TruSPECT Processing StationSpectrum Dynamics Medical, Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −5 | K021416 | Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −4 | K040053 | Precision VPS Impression Material | Discus Dental, Inc. | 2004 | — |
| −3 | K062450 | D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2006 | — |
| −2 | K072468 | Modification to D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2007 | 1 |
| −1 | K110507 | Cardiac Scanner and Processing System | Spectrum Dynamics (Israel), Ltd. | 2011 | — |
| 0 (this device) | K160120 | D-SPECT Processing and Reviewing Workstation | Spectrum Dynamics, Ltd. | 2016 | — |
| +1 | K212230 | TruSPECT Radiological Image Processing Station | Spectrum Dynamics Medical, Ltd. | 2021 | — |
| +2 | K253532 | TruSPECT Processing Station | Spectrum Dynamics Medical, Ltd. | 2025 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K110507 | Cardiac Scanner and Processing SystemSummary page 7…ry cardiac applications. The workstation can be a part of the FDA cleared D-SPECT ® Cardiac Scanner System (K110507) or integrated to a separate standalone post processing station. "SUMO" optional ap… | 2011 |
| † | K130884 | Xeleris 3.1 Processing and Review Workstation | 2013 |
| † | K130902 | Emory Cardiac Toolbox 3.2 | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212230 | TruSPECT Radiological Image Processing Station | 2021 | 1 |
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 22 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 7 of the 30 ancestors have a recall of any class.
- Of its descendants, K212230 (Spectrum Dynamics Medical, Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K110507.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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® Processing and Reviewing Workstation is intended for Processing, Reporting, Archiving, Display, Communication and Analysis of emission computerized tomography data using tools for imaging and automated review and quantification of Cardiac SPECT data. The D-SPECT® Processing and Reviewing Workstation is intended to work with Spectrum Dynamics’ D-SPECT® Cardiac Scanner System or as a separate standalone post processing workstation. The system…
Read the full statement (210 words)
The D-SPECT® Processing and Reviewing Workstation is intended for Processing, Reporting, Archiving, Display, Communication and Analysis of emission computerized tomography data using tools for imaging and automated review and quantification of Cardiac SPECT data.
The D-SPECT® Processing and Reviewing Workstation is intended to work with Spectrum Dynamics’ D-SPECT® Cardiac Scanner System or as a separate standalone post processing workstation.
The system is intended for use by the Nuclear Medicine (NM), Radiology or Electro Physiology Cardiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Dynamic, Multi-Gated) and tomographic three-dimensional scans (SPECT, Gated SPECT) acquired by gamma cameras. The system can run on a dedicated workstation or as part of Spectrum Dynamics’ D-SPECT® Cardiac Scanner System. The NM data can be coupled with registered and/or fused X-Ray CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. "SUMO" optional application enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of interest, identifying discreet uptake areas of mIBG I-123 (AdreView tm Iobenguane I-123 Injection) or similar agents within the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160120: D-SPECT Processing and Reviewing Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160120
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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