510(k) Report

510(k) · Cleared

Cleared

Cardius-1 and Cardis-2

K030085510(k) SpecialCleared Feb 5, 200327-day reviewClass II21 CFR 892.1200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Digirad Corp. · KPS System, Tomography, Computed, Emission

Cleared on Feb 5, 2003 after a 27-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.

Decided
Feb 5, 2003
Review
27 days
Class
Class II
Product code
KPS
Recalls
None
Predicates
0

9 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2007: 2 descendants cleared2008: 1 descendant cleared2010: 1 descendant cleared2009: 1 descendant cleared2013: 1 descendant cleared2011: 1 descendant cleared200020052010201520202025
  1. This deviceK030085 Cardius-1 and Cardis-2Digirad Corp. · 2003
  2. Descendant · cites it directly · 8 of its ownK051549 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
  3. Descendant · cites it directly · 7 of its ownK052430 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
  4. Descendant · cites it directly · 6 of its ownK070542 Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 2007
  5. Descendant · 2 generations on · 2 of its ownK100838 Ergo Imaging SystemDigirad Corp. · 2010
  6. Descendant · cites it directly · 1 of its ownK082368 Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems…Digirad Corp. · 2008

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2005: 22007: 22008: 12009: 12010: 12011: 12013: 1
2005high 2 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 9 · See all
  • K051549Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005 · cites it directly8descendants
  • K052430Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005 · cites it directly7descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030085Cardius-1 and Cardis-2Digirad Corp.2003—
+1K051549Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp.2005—
+1K052430Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp.2005—
+1K070542Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp.2007—
+2K100838Ergo Imaging SystemDigirad Corp.2010—
+1K082368Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect…Digirad Corp.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200720
200810
200910
201010
201110
201310
FIG. 1 — Lineage of K030085, 2003–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Digirad 2020tc SPECT Imaging System
Named without a submission number
—
*—ADAC Forte (cardiac applications only)
Named without a submission number
—

What descends from it? (9)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051549Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp.20058
K052430Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp.20057
K070542Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp.20076
K082368Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging…Digirad Corp.20081

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?

  • Of its descendants, K051549 (Digirad Corp., 2005) has gone furthest, with 8 descendants of its own.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPS

12in 2025

2007: 82008: 172009: 92010: 32011: 72012: 62013: 112014: 112015: 32016: 112017: 112018: 132019: 32020: 122021: 152022: 52023: 122024: 112025: 122026 (partial year): 6
2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007: 38 days median2008: 25 days median2009: 42 days median2010: 91 days median2011: 28 days median2012: 94 days median2013: 84 days median2014: 92 days median2015: 112 days median2016: 65 days median2017: 104 days median2018: 59 days median2019: 60 days median2020: 72 days median2021: 66 days median2022: 60 days median2023: 63 days median2024: 59 days median2025: 65 days median2026 (partial year): 67 days median
2007high 112 (2015) · low 25 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPS

16in 2025

2007: 222008: 162009: 142010: 42011: 342012: 132013: 132014: 182015: 52016: 162017: 112018: 12, 3 Class I2019: 5, 5 Class I2020: 82021: 42022: 8, 6 Class I2023: 6, 3 Class I2024: 152025: 162026 (partial year): 6
2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007: 382008: 112009: 152010: 442011: 562012: 342013: 2402014: 332015: 242016: 102017: 312018: 262019: 1052020: 222021: 102022: 152023: 222024: 232025: 36
2007high 240 (2013) · low 10 (2016)2025

MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078382238
200817251611
20099421415
2010391444
20117283456
20126941334
2013118413240
201411921833
20153112524
201611651610
2017111041131
2018135912 (3)26
20193605 (5)105
20201272822
20211566410
20225608 (6)15
202312636 (3)22
202411591523
202512651636
20266676—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

More from Digirad Corp.

16 FDA decisions under this applicant name. See the company

  • K123408Ergo Imaging SystemDigirad Corp. · 2013
  • K100838Ergo Imaging SystemDigirad Corp. · 2010
  • K083649Cardius 3 X-ActDigirad Corp. · 2009
  • K082904Stasys Motion Correction SoftwareDigirad Corp. · 2008
  • K082368Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging SystemDigirad Corp. · 2008

Recent decisions in KPS

The KPS category page

  • K261305Micsi-PetMicrostructure Imaging, Inc. · 2026
  • K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd. · 2026
  • K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia…Siemens Medical Solutions USA, Inc. · 2026
  • K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI…Shanghai United Imaging Healthcare Co., Ltd. · 2026
  • K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI…Shanghai United Imaging Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K030085 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030085: Cardius-1 and Cardis-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030085

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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