510(k) · Cleared
ClearedCardius-1, Cardius-2, Cardius-3, 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 Oct 4, 2005 as substantially equivalent to K982855 (Digirad Corp., 1998) and 6 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1989. 7 later devices descend from it.
- Decided
- Oct 4, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K885054 (1989). 11 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK885054 System Seventy SevenScinticor, Inc. · 1989
- 2 generations backK982855 Digirad 2020TC Spect Imaging SystemDigirad Corp. · 1998
- 1 generation backK051549 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
- This deviceK052430 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
- Descendant · cites it directly · 6 of its ownK070542 Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 2007
- Descendant · 2 generations on · 2 of its ownK100838 Ergo Imaging SystemDigirad Corp. · 2010
- Descendant · cites it directly · 1 of its ownK082368 Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems…Digirad Corp. · 2008
- Descendant · 3 generations on · 0 of its ownK123408 Ergo Imaging SystemDigirad Corp. · 2013
- Descendant · 3 generations on · 0 of its ownK110384 Dilon 6800 Acella (Acella)Dilon Technologies, Inc. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K070542Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 2007 · cites it directly6descendants
- K100838Ergo Imaging SystemDigirad Corp. · 2010 · 2 generations on2descendants
- K082368Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging…Digirad Corp. · 2008 · cites it directly1descendant
- K123408Ergo Imaging SystemDigirad Corp. · 2013 · 3 generations on0descendants
- K110384Dilon 6800 Acella (Acella)Dilon Technologies, Inc. · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K885054 | System Seventy Seven | Scinticor, Inc. | 1989 | — |
| −2 | K982855 | Digirad 2020TC Spect Imaging System | Digirad Corp. | 1998 | — |
| −1 | K051549 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System | Digirad Corp. | 2005 | — |
| 0 (this device) | 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 | — |
| +2 | K100838 | Ergo Imaging System | Digirad Corp. | 2010 | — |
| +1 | K082368 | Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect… | Digirad Corp. | 2008 | — |
| +3 | K123408 | Ergo Imaging System | Digirad Corp. | 2013 | — |
| +3 | K110384 | Dilon 6800 Acella (Acella) | Dilon Technologies, Inc. | 2011 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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? (7)
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 2…on to 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) Cardi… | 1998 |
| * | K030085 | Cardius-1 and Cardis-2Summary page 2…ing 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) Cardius-1, Cardius-2, Cardius-3, and 2020tc SPECT Imaging Systems cleared on July 13, 2005 under 5 10(k) #K051549… | 2003 |
| * | K051549 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemSummary page 2…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 5 10(k) #K051549 The Image Stabilization System Accessory when integrated with the cleared 2020tc and Cardius Model Digirad SPECT Imaging Systems… | 2005 |
| * | K972886 | MirageSummary page 2…rad SPECT Imaging Systems has the same function as the following predicate devices: the Motion Correction function module of Mirage software device (Segami Corporation, #K972886) and Digirad Cedars-Sinai Motion Correction (MoCo) Software Program device (#K023 110), which is currently used on the Digirad 20… | 1997 |
| * | K023110 | Cedars-Sinai Motion Correction (Moco) Software, Model 111005Summary page 1…ntially the same function as the currently cleared Cedar's Sinai Motion Correction Program (MoCo), cleared for use on Digirad SPECT Imaging Systems under Digirad 510(k) #K023 110. The proposed Image Stabilization System automatically produces an Image Stabilized Patient Study, corrected for patient motion,… | 2002 |
| * | K010509 | Cedars-Sinai BPGS and MocoSummary page 2…Stabilization System also performs the same functions as the MoCo Motion Correction Software in the following predicate devices: Cedars-Sinai BPGS and MoCo cleared under K010509 for GE/SMV America, and QPS/BPGS/MoCo Processing Applications cleared under K003264 for ELGEMS Ltd. G. Conclusions Drawn fro… | 2001 |
| * | K003264 | QPS/BPGS/Moco Processing Applications for Entegra WorkstationSummary page 2…Software in the following predicate devices: Cedars-Sinai BPGS and MoCo cleared under K010509 for GE/SMV America, and QPS/BPGS/MoCo Processing Applications cleared under K003264 for ELGEMS Ltd. G. Conclusions Drawn from Testing Testing was performed to analyze the content of corrected phantom studies… | 2000 |
What descends from it? (7)
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 16 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K070542 (Digirad Corp., 2007) has gone furthest, with 6 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.
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: 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…
Read the full statement (137 words)
Cardius-1, Cardius-2, Cardius-3:
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 Imager TM 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/K052430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052430: Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052430
Report an extraction error
Are you the manufacturer?
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