510(k) · Cleared
Recalled · 2004Cardiocam Model 9CSY0799
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Danish Diagnostic Development A/S · KPS System, Tomography, Computed, Emission
Cleared on Jun 8, 2001 after a 14-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 of the 102 devices in its family, counting itself, have a Class I recall. 101 later devices descend from it. It has been recalled once.
- Decided
- Jun 8, 2001
- Review
- 14 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 0
101 later devices descend from it, 3 citing it directly. 6 of the 102 devices in this family, counting this one, have a Class I recall.
- This deviceK011611 Cardiocam Model 9CSY0799Danish Diagnostic Development A/S · 2001
- Descendant · cites it directly · 98 of its ownK031825 C.CAMDanish Diagnostic Development A/S · 2003 · Recalled
- Descendant · 2 generations on · 85 of its ownK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 83 of its ownK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 66 of its ownK131634 SymbiaSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- Descendant · 5 generations on · 65 of its ownK142006 Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · Recalled
Showing 5 of 101 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 101 · See all- K031825C.CAMDanish Diagnostic Development A/S · 2003 · cites it directly98descendants
- K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · 2 generations on85descendants
- K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · 3 generations on83descendants
- K131634SymbiaSiemens Medical Solutions USA, Inc. · 2013 · 4 generations on66descendants
- K142006Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · 5 generations on65descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011611 | Cardiocam Model 9CSY0799 | Danish Diagnostic Development A/S | 2001 | — |
| +1 | K031825 | C.CAM | Danish Diagnostic Development A/S | 2003 | 2 |
| +2 | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | 2 |
| +3 | K082506 | Symbia, Version 4.0 | Siemens Medical Solutions USA, Inc. | 2008 | 9 |
| +4 | K131634 | Symbia | Siemens Medical Solutions USA, Inc. | 2013 | 7 |
| +5 | K142006 | Symbia 6.0 | Siemens Medical Solutions USA, Inc. | 2014 | 9 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 1 |
| 2010 | 1 | 0 |
| 2011 | 4 | 2 |
| 2012 | 1 | 1 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 4 | 1 |
| 2017 | 1 | 0 |
| 2018 | 5 | 1 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 12 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 10 | 0 |
| 2025 | 14 | 0 |
| 2026 | 11 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (101)
See all 1013 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 21, 2004 | Not classified | Z-1079-04 | Other | Software problems may cause the detector head to drift unexpectedly |
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.
- K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K111445Discovery NM 630GE Healthcare · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113350Brivo NM 615GE Healthcare · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121019Optima NM/CT 640GE Healthcare · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K031825 (Danish Diagnostic Development A/S, 2003) has gone furthest, with 98 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?
The Cardiocam system is a dual head system designed to acquire data for cardxac multi-slice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio phaml.aceutlcals, images are produced representmg the internal distribution of radioactivity in the body. The system allows you to acquire data for lugh resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc-99m, T1-201, Co-57.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011611: Cardiocam Model 9CSY0799.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011611
Report an extraction error
Are you the manufacturer?
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