510(k) · Cleared
Recalled · 2004Modification to: Ecat Lso Pet/CT Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cti Pet Systems, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Oct 31, 2001 as substantially equivalent to K002715 (Cti Pet Systems, Inc., 2000) after a 9-day review. Its family tree reaches back 1 generation to 2000. 1 of the 75 devices in its family, counting itself, has a Class I recall. 73 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 31, 2001
- Review
- 9 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002715 (2000). 73 later devices descend from it, 4 citing it directly. 1 of the 75 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- This deviceK013504 Modification to: Ecat Lso Pet/CT ScannerCti Pet Systems, Inc. · 2001
- Descendant · cites it directly · 71 of its ownK023518 Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002 · Recalled
- Descendant · cites it directly · 68 of its ownK033431 Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 67 of its ownK042467 Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 66 of its ownK050509 Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005
- Descendant · 3 generations on · 65 of its ownK060060 Biograph 6Siemens Medical Solutions USA, Inc. · 2006
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200213 Biograph mMR with syngo MR E11P-AP01 system…8 generations on · 2020
Most influential descendants
Showing 5 of 73 · See all- K023518Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002 · cites it directly71descendants
- K033431Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc. · 2003 · cites it directly68descendants
- K042467Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · 2 generations on67descendants
- K050509Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005 · 2 generations on66descendants
- K060060Biograph 6Siemens Medical Solutions USA, Inc. · 2006 · 3 generations on65descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002715 | Ecat Pet Scanner | Cti Pet Systems, Inc. | 2000 | 2 |
| 0 (this device) | K013504 | Modification to: Ecat Lso Pet/CT Scanner | Cti Pet Systems, Inc. | 2001 | — |
| +1 | K023518 | Ecat Lso Pet/CT 16 | Cti Pet Systems, Inc. | 2002 | 1 |
| +1 | K033431 | Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez | Cti Pet Systems, Inc. | 2003 | 1 |
| +2 | K042467 | Lso Pet/CT Hirez 64 | Cti Pet Systems, Inc. | 2004 | 1 |
| +2 | K050509 | Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I | Cti Pet Systems, Inc. | 2005 | — |
| +3 | K060060 | Biograph 6 | Siemens Medical Solutions USA, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 1 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 0 |
| 2026 | 7 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K002715 | Ecat Pet ScannerSummary page 1…ion Computed Tomography System per 21 CFR 892.1200 Marketed Device to Which Equivalence is Claimed Device Manufacturer 510(k) Number ECAT PET/CT CTI PET Systems (CPS) K002715 Device Description and Comparison The ECAT LSO PET/CT is a combined positron emission tomography (PET) and X-ray computed tomog… | 2000 |
What descends from it? (73)
See all 734 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 27, 2004 | Not classified | Z-0547-05 | Other | Misalignment of CT and PET scans from performing additional CT scans may produce an incorrect fused data set. In performing additional CT scans, the original PET and CT scans may become misaligned and produce an incorrect fused data set. |
| Oct 2, 2003 | Not classified | Z-0106-04 | Other | CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion. |
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.
- K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc. · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 11 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?
The CPS/Siemens ECAT LSO PET/CT system is a combined positron emission tomography (PET) and X-ray computed tomography (CT) scanner. The ECAT LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2)…
Read the full statement (168 words)
The CPS/Siemens ECAT LSO PET/CT system is a combined positron emission tomography (PET) and X-ray computed tomography (CT) scanner. The ECAT LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)
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/K013504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013504: Modification to: Ecat Lso Pet/CT Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013504
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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