510(k) · Cleared
ClearedLso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I
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 Mar 25, 2005 as substantially equivalent to K033431 (Cti Pet Systems, Inc., 2003) and 1 other predicate after a 24-day review. Its family tree reaches back 5 generations to 2000. 1 of the 75 devices in its family, counting itself, has a Class I recall. 66 later devices descend from it.
- Decided
- Mar 25, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K002715 (2000). 8 ancestors in all, the oldest K843696 (1985). 66 later devices descend from it, 2 citing it directly. 1 of the 75 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 4 generations backK013504 Modification to: Ecat Lso Pet/CT ScannerCti Pet Systems, Inc. · 2001 · Recalled
- 3 generations backK023518 Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002 · Recalled
- 2 generations backK033431 Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc. · 2003 · Recalled
- 1 generation backK042467 Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · Recalled
- This deviceK050509 Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005
- Descendant · cites it directly · 65 of its ownK060060 Biograph 6Siemens Medical Solutions USA, Inc. · 2006
- Descendant · cites it directly · 64 of its ownK060631 Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 62 of its ownK081453 Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008
- Descendant · 3 generations on · 38 of its ownK101550 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2010
- Descendant · 4 generations on · 37 of its ownK113448 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2011
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200213 Biograph mMR with syngo MR E11P-AP01 system…6 generations on · 2020
Most influential descendants
Showing 5 of 66 · See all- K060060Biograph 6Siemens Medical Solutions USA, Inc. · 2006 · cites it directly65descendants
- K060631Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · cites it directly64descendants
- K081453Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008 · 2 generations on62descendants
- K101550Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2010 · 3 generations on38descendants
- K113448Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2011 · 4 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002715 | Ecat Pet Scanner | Cti Pet Systems, Inc. | 2000 | 2 |
| −4 | K013504 | Modification to: Ecat Lso Pet/CT Scanner | Cti Pet Systems, Inc. | 2001 | 2 |
| −3 | K023518 | Ecat Lso Pet/CT 16 | Cti Pet Systems, Inc. | 2002 | 1 |
| −2 | K033431 | Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez | Cti Pet Systems, Inc. | 2003 | 1 |
| −1 | K042467 | Lso Pet/CT Hirez 64 | Cti Pet Systems, Inc. | 2004 | 1 |
| 0 (this device) | K050509 | Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I | Cti Pet Systems, Inc. | 2005 | — |
| +1 | K060060 | Biograph 6 | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +1 | K060631 | Biograph 64 and Biograph 40 | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +2 | K081453 | Biograph HD Family | Siemens Medical Solutions USA, Inc. | 2008 | — |
| +3 | K101550 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +4 | K113448 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K033431 | Lso Pet/CT Hirez and Lso Pet/CT 16 HirezSummary page 1…Equivalence is Claimed Device Manufacturer 510k~Num~ber LSO PET/CT HiRez and CTI PET Systems (CPS) K033431 HiRezl6 LSO PET/CT HiRez 64 CTI PET Systems (CPS) K042467 Device Description: The CPS LSO… | 2003 |
| * | K042467 | Lso Pet/CT Hirez 64Summary page 1…Num~ber LSO PET/CT HiRez and CTI PET Systems (CPS) K033431 HiRezl6 LSO PET/CT HiRez 64 CTI PET Systems (CPS) K042467 Device Description: The CPS LSO PET/CT Hi-Rez series of scanners are combined Positron Emission Tomography and X-Ray Computed… | 2004 |
What descends from it? (66)
See all 662 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)
No FDA recall names this device.
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 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 12 months on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K060060 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 65 descendants of its own.
- 1 other device also cites its predicate K033431.
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 LSO PET/CT HiRez Series Scanners are combined positron emission tomography (PET) and X-ray computed tomography (CT) scannesr. The 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…
Read the full statement (167 words)
The CPS LSO PET/CT HiRez Series Scanners are combined positron emission tomography (PET) and X-ray computed tomography (CT) scannesr. The 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 as stated in the FDA summary.
https://510kreport.com/device/K050509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050509: Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050509
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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