510(k) · Cleared
ClearedCardius 3 X-Act
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 Mar 9, 2009 as substantially equivalent to K080927 (Philips Medical Systems (Cleveland), Inc., 2008) and 2 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1989. 6 of the 23 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 9, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K885054 (1989). 22 ancestors in all. No later device cites it as a predicate yet. 6 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK885054 System Seventy SevenScinticor, Inc. · 1989
- 5 generations backK982855 Digirad 2020TC Spect Imaging SystemDigirad Corp. · 1998
- 4 generations backK051549 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
- 3 generations backK052430 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
- 2 generations backK070542 Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 2007
- 1 generation backK082368 Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems…Digirad Corp. · 2008
- This deviceK083649 Cardius 3 X-ActDigirad Corp. · 2009
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K885054 | System Seventy Seven | Scinticor, Inc. | 1989 | — |
| −5 | K982855 | Digirad 2020TC Spect Imaging System | Digirad Corp. | 1998 | — |
| −4 | K051549 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System | Digirad Corp. | 2005 | — |
| −3 | K052430 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System | Digirad Corp. | 2005 | — |
| −2 | K070542 | Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems | Digirad Corp. | 2007 | — |
| −1 | K082368 | Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect… | Digirad Corp. | 2008 | — |
| 0 (this device) | 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 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 1 |
| 1999 | 1 | 1 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 1 |
| 2005 | 1 | 1 |
| 2006 | 1 | 1 |
| 2008 | 1 | 1 |
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.
6 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K080927 | Brightview VCT Imaging SystemSummary page 1…Devices The Cardius 3 X-ACT Imaging System is substantially equivalent to the following cleared devices: (1) BrightView VCT Imaging System cleared April 11, 2008 under K080927 for Philips Medical Systems (2) Cardius 3 XPO Imaging System cleared March 23, 2007 under K070542, and September 12, 2008 under… | 2008 |
| * | K070542 | Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsSummary page 1…ces: (1) BrightView VCT Imaging System cleared April 11, 2008 under K080927 for Philips Medical Systems (2) Cardius 3 XPO Imaging System cleared March 23, 2007 under K070542, and September 12, 2008 under K082368 for Digirad Corporation. E. Device Description The Cardius ® 3 X-ACT Imaging system i… | 2007 |
| * | K082368 | Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging…Summary page 1…em cleared April 11, 2008 under K080927 for Philips Medical Systems (2) Cardius 3 XPO Imaging System cleared March 23, 2007 under K070542, and September 12, 2008 under K082368 for Digirad Corporation. E. Device Description The Cardius ® 3 X-ACT Imaging system is a gamma camera for the acquisition a… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080927Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
- K062298Apollo Gamma Camera SystemAdac Laboratories · 2006 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
- K052434Hawkeye 4 Option for Dual-Head Variable Angle Gamma CameraGE Medical Systems · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K033254Forte Gamma Camera SystemAdac Laboratories · 2003 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 13 Class I recalls
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 3 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
- K982911FORTEAdac Laboratories · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 12 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 22 ancestors have a recall of any class; 6 have a Class I recall.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Cardius 3 X-ACT Imaging System is a gamma camera for Single Photon Emission Computed Tomography (SPECT) integrated with an attenuation device consisting of an x-ray generator. The Cardius 3 X-ACT Imaging System is intended for use in the generation of cardiac studies, including planar and SPECT studies, in nuclear medicine applications. Cardius 3 X-ACT produces non-attenuation corrected SPECT Images and attenuation corrected SPECT images with x-ray transmission data that may also be corrected for scatter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083649: Cardius 3 X-Act.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083649
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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