510(k) · Cleared
Recalled · 2004Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez
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 Nov 20, 2003 as substantially equivalent to K013504 (Cti Pet Systems, Inc., 2001) and 1 other predicate after a 23-day review. Its family tree reaches back 3 generations to 2000. 1 of the 72 devices in its family, counting itself, has a Class I recall. 68 later devices descend from it. It has been recalled once.
- Decided
- Nov 20, 2003
- Review
- 23 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002715 (2000). 68 later devices descend from it, 2 citing it directly. 1 of the 72 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 2 generations backK013504 Modification to: Ecat Lso Pet/CT ScannerCti Pet Systems, Inc. · 2001 · Recalled
- 1 generation backK023518 Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002 · Recalled
- This deviceK033431 Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc. · 2003
- Descendant · cites it directly · 67 of its ownK042467 Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · Recalled
- Descendant · cites it directly · 66 of its ownK050509 Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005
- Descendant · 2 generations on · 65 of its ownK060060 Biograph 6Siemens Medical Solutions USA, Inc. · 2006
- Descendant · 2 generations on · 64 of its ownK060631 Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 62 of its ownK081453 Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200213 Biograph mMR with syngo MR E11P-AP01 system…7 generations on · 2020
Most influential descendants
Showing 5 of 68 · See all- K042467Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · cites it directly67descendants
- K050509Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005 · cites it directly66descendants
- K060060Biograph 6Siemens Medical Solutions USA, Inc. · 2006 · 2 generations on65descendants
- K060631Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · 2 generations on64descendants
- K081453Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008 · 3 generations on62descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002715 | Ecat Pet Scanner | Cti Pet Systems, Inc. | 2000 | 2 |
| −2 | K013504 | Modification to: Ecat Lso Pet/CT Scanner | Cti Pet Systems, Inc. | 2001 | 2 |
| −1 | K023518 | Ecat Lso Pet/CT 16 | Cti Pet Systems, Inc. | 2002 | 1 |
| 0 (this device) | K033431 | Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez | Cti Pet Systems, Inc. | 2003 | — |
| +1 | K042467 | Lso Pet/CT Hirez 64 | Cti Pet Systems, Inc. | 2004 | 1 |
| +1 | K050509 | Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I | Cti Pet Systems, Inc. | 2005 | — |
| +2 | K060060 | Biograph 6 | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +2 | K060631 | Biograph 64 and Biograph 40 | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +3 | K081453 | Biograph HD Family | Siemens Medical Solutions USA, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 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 | 6 | 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? (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 |
|---|---|---|---|
| * | K013504 | Modification to: Ecat Lso Pet/CT ScannerSummary page 1…y of combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. These dual modality tomographs are modified versions of the ECAT LSO PETKT (K013504) and ECAT LSO PETKT 16 (K023518) and will utilize the same Siemens SOMATOM CT scanner components as their respective predicate PE… | 2001 |
| * | K023518 | Ecat Lso Pet/CT 16Summary page 1…tomography (PET) and X-ray computed tomography (CT) scanners. These dual modality tomographs are modified versions of the ECAT LSO PETKT (K013504) and ECAT LSO PETKT 16 (K023518) and will utilize the same Siemens SOMATOM CT scanner components as their respective predicate PETKT scanners. However, on this n… | 2002 |
What descends from it? (68)
See all 682 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. |
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 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K042467 (Cti Pet Systems, Inc., 2004) has gone furthest, with 67 descendants of its own.
- 3 other devices also cite its predicate K013504.
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 LSO PET/CT Hi Rez and LSO PET/CT 16 HiRez tomographic scanner systems are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The LSO PETKT Hi Rez and LSO PETKT 16 HiRez scanners are 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…
Read the full statement (180 words)
The LSO PET/CT Hi Rez and LSO PET/CT 16 HiRez tomographic scanner systems are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The LSO PETKT Hi Rez and LSO PETKT 16 HiRez scanners are 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 as stated in the FDA summary.
https://510kreport.com/device/K033431 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033431: Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033431
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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