510(k) · Cleared
ClearedEcat Pet/CT; Ecat Lso Pet/CT; Ecat Lso Pet/CT 16
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 25, 2002 as substantially equivalent to K002715 (Cti Pet Systems, Inc., 2000) and 2 other predicates after a 13-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Nov 25, 2002
- Review
- 13 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K002715 (2000). 1 later device descends from it, 1 citing it directly.
- 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 deviceK023768 Ecat Pet/CT; Ecat Lso Pet/CT; Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK042428 SCEPTREP3 Pet/CTHitachi Medical Systems America, Inc. · 2004 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K042428SCEPTREP3 Pet/CTHitachi Medical Systems America, Inc. · 2004 · cites it directly0descendants
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) | K023768 | Ecat Pet/CT; Ecat Lso Pet/CT; Ecat Lso Pet/CT 16 | Cti Pet Systems, Inc. | 2002 | — |
| +1 | K042428 | SCEPTREP3 Pet/CT | Hitachi Medical Systems America, Inc. | 2004 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 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.
Planning a device in KPS? 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? (3)
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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042428 | SCEPTREP3 Pet/CT | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 12 months on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K042428 (Hitachi Medical Systems America, Inc., 2004) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K002715.
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 PETKT Patient Handling System (PHS) is a system component of CPS ECAT PETKT tomographic scanner systems, which are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The PET/CT Patient Handling System is used to support and move a patient through the PETKT scanner while CT and PET diagnostic image data are being acquired from the patient. The ECAT PET/CT scanners are intended to be utilized by appropriately…
Read the full statement (208 words)
The PETKT Patient Handling System (PHS) is a system component of CPS ECAT PETKT tomographic scanner systems, which are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The PET/CT Patient Handling System is used to support and move a patient through the PETKT scanner while CT and PET diagnostic image data are being acquired from the patient.
The ECAT PET/CT 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 these systems 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/K023768 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023768: Ecat Pet/CT; Ecat Lso Pet/CT; Ecat Lso Pet/CT 16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023768
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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