510(k) · Cleared
ClearedCardiospect D90/Cardio Cam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuclear Cardiology Systems, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Jun 17, 2002 as substantially equivalent to K013353 (Nuclear Cardiology Systems, Inc., 2002) after a 13-day review. Its family tree reaches back 1 generation to 2002. 3 later devices descend from it.
- Decided
- Jun 17, 2002
- Review
- 13 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013353 (2002). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK013353 Neurospectquad Gamma CameraNuclear Cardiology Systems, Inc. · 2002
- This deviceK021823 Cardiospect D90/Cardio CamNuclear Cardiology Systems, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK033874 MyolightGe Medical Systems F.I. Haifa · 2003
- Descendant · cites it directly · 1 of its ownK033001 Apex Detector Electronics & Acquisition Interface, Model XL-4Transphoton Corporation · 2003
- Descendant · 2 generations on · 0 of its ownK070589 C!Transphoton Corporation · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013353 | Neurospectquad Gamma Camera | Nuclear Cardiology Systems, Inc. | 2002 | — |
| 0 (this device) | K021823 | Cardiospect D90/Cardio Cam | Nuclear Cardiology Systems, Inc. | 2002 | — |
| +1 | K033874 | Myolight | Ge Medical Systems F.I. Haifa | 2003 | — |
| +1 | K033001 | Apex Detector Electronics & Acquisition Interface, Model XL-4 | Transphoton Corporation | 2003 | — |
| +2 | K070589 | C! | Transphoton Corporation | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2007 | 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 18.7 · 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? (1)
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 |
|---|---|---|---|
| * | K013353 | Neurospectquad Gamma Camera | 2002 |
What descends from it? (3)
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?
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?
Intended use is to detect & image the distribution of radionuclides in the body when the radiopharmaceutical is administered in the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021823 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021823: Cardiospect D90/Cardio Cam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021823
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