510(k) · Cleared
ClearedD-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 20, 2006 as substantially equivalent to K031825 (Danish Diagnostic Development A/S, 2003) and 3 other predicates after a 59-day review. Its family tree reaches back 3 generations to 1994. 14 later devices descend from it.
- Decided
- Oct 20, 2006
- Review
- 59 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K943574 (1994). 16 ancestors in all, the oldest K885054 (1989). 14 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 2 generations backK021416 Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 1 generation backK040053 Precision VPS Impression MaterialDiscus Dental, Inc. · 2004
- This deviceK062450 D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2006
- Descendant · cites it directly · 10 of its ownK072468 Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · Recalled
- Descendant · 2 generations on · 9 of its ownK110507 Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011
- Descendant · 3 generations on · 5 of its ownK161740 D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016
- Descendant · 4 generations on · 4 of its ownK180514 Veriton NMSpectrum Dynamics Medical, Ltd. · 2018
- Descendant · 5 generations on · 3 of its ownK182484 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · cites it directly10descendants
- K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011 · 2 generations on9descendants
- K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016 · 3 generations on5descendants
- K180514Veriton NMSpectrum Dynamics Medical, Ltd. · 2018 · 4 generations on4descendants
- K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −2 | K021416 | Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −1 | K040053 | Precision VPS Impression Material | Discus Dental, Inc. | 2004 | — |
| 0 (this device) | K062450 | D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2006 | — |
| +1 | K072468 | Modification to D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2007 | 1 |
| +2 | K110507 | Cardiac Scanner and Processing System | Spectrum Dynamics (Israel), Ltd. | 2011 | — |
| +3 | K161740 | D-SPECT Scanner, D-SPECT L Scanner | Spectrum Dynamics Medical, Ltd. | 2016 | — |
| +4 | K180514 | Veriton NM | Spectrum Dynamics Medical, Ltd. | 2018 | — |
| +5 | K182484 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K031825 | C.CAMSummary page 2…t TM Cardiac Scanner System is substantially equivalent to a combination of the following predicate devices: -Virgo (K031825) manufactured by 3D, Danish Diagnostic Development A/S (device a.k.a C.Cam, owned by Siemens… | 2003 |
| * | K053062 | Cardiarc Spect Imaging Device, Model CQ103-RV2Summary page 2…TM device. radionuclides similar to the D-Spect - Cardiarc (K053062) manufactured by Cardiarc Ltd. Cardiarc is a SPECT imaging device which is intended for production of… | 2006 |
| * | K040053 | Precision VPS Impression MaterialSummary page 2…-a) SmartBand (Class I 510(k) exempt), provides patient identification - b) CareCheck (BK040053)- used in blood banks; provides patient and product identification. - c) VeriC… | 2004 |
| * | 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. | |
| * | — | SmartBand Named without a submission number |
What descends from it? (14)
See all 142 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 12 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K072468 (Spectrum Dynamics, Ltd., 2007) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K031825.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
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/K062450 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062450: D-Spect Cardiac Scanner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062450
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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