510(k) · Cleared
Recalled · Class II · 2015C.Cam-AC
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 15, 2005 as substantially equivalent to K040616 (Danish Diagnostic Development A/S, 2004) and 1 other predicate after a 12-day review. Its family tree reaches back 1 generation to 1997. 6 of the 89 devices in its family, counting itself, have a Class I recall. 86 later devices descend from it. It has been recalled once.
- Decided
- Jun 15, 2005
- Review
- 12 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K963983 (1997). 2 ancestors in all. 86 later devices descend from it, 1 citing it directly. 6 of the 89 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK963983 E. Cam Profile Attenuation CorrectionSiemens Corp. · 1997
- This deviceK051460 C.Cam-ACDanish Diagnostic Development A/S · 2005
- Descendant · cites it directly · 85 of its ownK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 83 of its ownK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 66 of its ownK131634 SymbiaSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 65 of its ownK142006 Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 5 generations on · 63 of its ownK162483 Symbia Intevo BoldSiemens Medical Solutions USA, Inc. · 2017
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 86 · See all- K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · cites it directly85descendants
- K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · 2 generations on83descendants
- K131634SymbiaSiemens Medical Solutions USA, Inc. · 2013 · 3 generations on66descendants
- K142006Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · 4 generations on65descendants
- K162483Symbia Intevo BoldSiemens Medical Solutions USA, Inc. · 2017 · 5 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963983 | E. Cam Profile Attenuation Correction | Siemens Corp. | 1997 | — |
| 0 (this device) | K051460 | C.Cam-AC | Danish Diagnostic Development A/S | 2005 | — |
| +1 | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | 2 |
| +2 | K082506 | Symbia, Version 4.0 | Siemens Medical Solutions USA, Inc. | 2008 | 9 |
| +3 | K131634 | Symbia | Siemens Medical Solutions USA, Inc. | 2013 | 7 |
| +4 | K142006 | Symbia 6.0 | Siemens Medical Solutions USA, Inc. | 2014 | 9 |
| +5 | K162483 | Symbia Intevo Bold | Siemens Medical Solutions USA, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 1 |
| 2010 | 1 | 0 |
| 2011 | 3 | 2 |
| 2012 | 1 | 1 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 1 |
| 2017 | 1 | 0 |
| 2018 | 4 | 1 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 10 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 10 | 0 |
| 2025 | 13 | 0 |
| 2026 | 11 | 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.
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040616 | Cardiomd-ACSummary page 1…d tomography system 3 Predicate Device: I. CardioMD-AC. 3D, Danish Diattnostic Development A/S 510(K) Number: K040616. 1 ~ ~ ~~ -21. ~Ecam-AMC. Siemens Medical Solutions USA, Inc.… | 2004 |
| * | K963983 | E. Cam Profile Attenuation CorrectionSummary page 1…: K040616. 1 ~ ~ ~~ -21. ~Ecam-AMC. Siemens Medical Solutions USA, Inc. K963983. Refer to section C3 Comparison of the New and Predicate Device, subpart;… | 1997 |
What descends from it? (86)
See all 861 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072567 | Symbia-E, Model 10275879 | 2007 | 85 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 6, 2015 | Class II | Z-1784-2015 | Nonconforming Material/Component | The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes. |
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 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K111445Discovery NM 630GE Healthcare · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113350Brivo NM 615GE Healthcare · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121019Optima NM/CT 640GE Healthcare · 2012 · 5 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K072567 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 85 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?
Attenuation correction is a method where the emission images acquired during SPECT acquisitions are compensated for attenuation within the patient. The purpose of attenuation correction is to compensate for varying attenuation of gamma rays in the body.
The intended use of the c.cam Attenuation Correction option is to provide the customer with means to measure the attenuation of gamma rays within the body of a patient, when using a c.cam gamma camera system for SPECT studies, and to map the measured attenuation into images that can be used to compensate emission images for the attenuation. The c.cam-AC includes additional acquisition of data for scatter correction of these images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051460: C.Cam-AC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051460
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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