510(k) · Cleared
ClearedCardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digirad Corp. · KPS System, Tomography, Computed, Emission
Cleared on Sep 12, 2008 as substantially equivalent to K982855 (Digirad Corp., 1998) and 4 other predicates after a 25-day review. Its family tree reaches back 5 generations to 1989. 1 later device descends from it.
- Decided
- Sep 12, 2008
- Review
- 25 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K885054 (1989). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK885054 System Seventy SevenScinticor, Inc. · 1989
- 4 generations backK982855 Digirad 2020TC Spect Imaging SystemDigirad Corp. · 1998
- 3 generations backK051549 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
- 2 generations backK052430 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
- 1 generation backK070542 Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 2007
- This deviceK082368 Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems…Digirad Corp. · 2008
- Descendant · cites it directly · 0 of its ownK083649 Cardius 3 X-ActDigirad Corp. · 2009
Most influential descendants
Showing 1 of 1 · See all- K083649Cardius 3 X-ActDigirad Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K885054 | System Seventy Seven | Scinticor, Inc. | 1989 | — |
| −4 | K982855 | Digirad 2020TC Spect Imaging System | Digirad Corp. | 1998 | — |
| −3 | K051549 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System | Digirad Corp. | 2005 | — |
| −2 | K052430 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System | Digirad Corp. | 2005 | — |
| −1 | K070542 | Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems | Digirad Corp. | 2007 | — |
| 0 (this device) | K082368 | Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect… | Digirad Corp. | 2008 | — |
| +1 | K083649 | Cardius 3 X-Act | Digirad Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K982855 | Digirad 2020TC Spect Imaging SystemSummary page 1…the following Digirad cleared devices: (1) 2020tc SPECT Imaging System and the SPECTour Chair (SPECT Imaging System), cleared on November 9, 1998 under 510(k) #K982855; and (2) Cardius-1 and Cardius-2 SPECT Imaging System cleared on February 5, 2003 under 5 10(k) #K030085. (3) Cardiu… | 1998 |
| * | K030085 | Cardius-1 and Cardis-2Summary page 1…tem), cleared on November 9, 1998 under 510(k) #K982855; and (2) Cardius-1 and Cardius-2 SPECT Imaging System cleared on February 5, 2003 under 5 10(k) #K030085. (3) Cardius-1, Cardius-2, Cardius-3, and 2020tc SPECT Imaging Systems cleared on July 13, 2005 under 510(k) #K05 1549… | 2003 |
| * | K051549 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemSummary page 1…on February 5, 2003 under 5 10(k) #K030085. (3) Cardius-1, Cardius-2, Cardius-3, and 2020tc SPECT Imaging Systems cleared on July 13, 2005 under 510(k) #K05 1549 (4) Cardius-1, Cardius-2, Cardius-3, and 2020tc SPECT lImaging Systems cleared on October 4, 2005 under 5 10(k) #K05243… | 2005 |
| * | K052430 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemSummary page 1…on July 13, 2005 under 510(k) #K05 1549 (4) Cardius-1, Cardius-2, Cardius-3, and 2020tc SPECT lImaging Systems cleared on October 4, 2005 under 5 10(k) #K05243 0 (5) Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO, and 2020tc: SPECT Imaging Systems cleared on March 23, 2007 under 510(… | 2005 |
| * | K070542 | Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsSummary page 1…ober 4, 2005 under 5 10(k) #K05243 0 (5) Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO, and 2020tc: SPECT Imaging Systems cleared on March 23, 2007 under 510(k) #K070542 G. Conclusions Drawn from Testing Digirad testing performed with cardiac phantom images and via a multicenter… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083649 | Cardius 3 X-Act | 2009 | 0 |
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 19 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K083649 (Digirad Corp., 2009) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K982855.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Cardius-1, Cardius-2, Cardius-3, Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO Imaging Systems: The Cardius product models are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications. 2020tc SPECT Imaging System: The Digirad 2020tc SPECT Imaging system is intended for use in the generation of both planar and Single Photon Emission Computed…
Read the full statement (147 words)
Cardius-1, Cardius-2, Cardius-3, Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO Imaging Systems:
The Cardius product models are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications.
2020tc SPECT Imaging System:
The Digirad 2020tc SPECT Imaging system is intended for use in the generation of both planar and Single Photon Emission Computed Tomography (SPECT) clinical images in nuclear medicine applications. The Digirad SPECT Rotating Chair is used in conjunction with the Digirad 2020tc ImagerTM to obtain SPECT images in patients who are seated in an upright position.
Specifically, the 2020tc ImagerTM is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082368 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082368: Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082368
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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