510(k) · Cleared
ClearedNeurospectquad Gamma Camera
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 Mar 4, 2002 after a 146-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Mar 4, 2002
- Review
- 146 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK013353 Neurospectquad Gamma CameraNuclear Cardiology Systems, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK021823 Cardiospect D90/Cardio CamNuclear Cardiology Systems, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK033874 MyolightGe Medical Systems F.I. Haifa · 2003
- Descendant · 2 generations on · 1 of its ownK033001 Apex Detector Electronics & Acquisition Interface, Model XL-4Transphoton Corporation · 2003
- Descendant · cites it directly · 0 of its ownK132347 Multicam 3000 EcoInter Medical Medizintechnik GmbH · 2013
- Descendant · 3 generations on · 0 of its ownK070589 C!Transphoton Corporation · 2007
Most influential descendants
Showing 5 of 5 · See all- K021823Cardiospect D90/Cardio CamNuclear Cardiology Systems, Inc. · 2002 · cites it directly3descendants
- K033874MyolightGe Medical Systems F.I. Haifa · 2003 · 2 generations on1descendant
- K033001Apex Detector Electronics & Acquisition Interface, Model XL-4Transphoton Corporation · 2003 · 2 generations on1descendant
- K132347Multicam 3000 EcoInter Medical Medizintechnik GmbH · 2013 · cites it directly0descendants
- K070589C!Transphoton Corporation · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013353 | Neurospectquad Gamma Camera | Nuclear Cardiology Systems, Inc. | 2002 | — |
| +1 | K021823 | Cardiospect D90/Cardio Cam | Nuclear Cardiology Systems, Inc. | 2002 | — |
| +2 | K033874 | Myolight | Ge Medical Systems F.I. Haifa | 2003 | — |
| +2 | K033001 | Apex Detector Electronics & Acquisition Interface, Model XL-4 | Transphoton Corporation | 2003 | — |
| +1 | K132347 | Multicam 3000 Eco | Inter Medical Medizintechnik GmbH | 2013 | — |
| +3 | K070589 | C! | Transphoton Corporation | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 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 18.7 · 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 |
|---|---|---|---|
| * | — | Picker Prism 3000 Named without a submission number |
What descends from it? (5)
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?
- Of its descendants, K021823 (Nuclear Cardiology Systems, Inc., 2002) has gone furthest, with 3 descendants of its own.
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?
NeuroSpect QUAD is intended to detect and obtain planar and SPECT images of the distribution of a gamma emitting radionuclide in the brain and store the data, when the radionuclide is administered in the body.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013353: Neurospectquad Gamma Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013353
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026