510(k) · Cleared
ClearedImagenpro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiovascular Imaging Technologies, LLC · KPS System, Tomography, Computed, Emission
Cleared on Mar 17, 2005 as substantially equivalent to K002584 (Cti Pet Systems, Inc., 2000) and 1 other predicate after a 31-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Mar 17, 2005
- Review
- 31 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010641 (2001). 3 ancestors in all, the oldest K002584 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 1 generation backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- This deviceK050366 ImagenproCardiovascular Imaging Technologies, LLC · 2005
- Descendant · cites it directly · 0 of its ownK173547 ImagenUniversalCardiovascular Imaging Technologies · 2018
Most influential descendants
Showing 1 of 1 · See all- K173547ImagenUniversalCardiovascular Imaging Technologies · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −1 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| 0 (this device) | K050366 | Imagenpro | Cardiovascular Imaging Technologies, LLC | 2005 | — |
| +1 | K173547 | ImagenUniversal | Cardiovascular Imaging Technologies | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K002584 | Ecat Accel Pet ScannerSummary page 1…TmagcnPRO" h Classification Name: System, Emission Computed Tomography C. Prdct Devices: Siemens/CTI Accel -- CPS Innovations - K002584 GE Discovery LS - General Electric - K023988 D. Device Description: lmagcnPRO TM i… | 2000 |
| * | K023988 | GE Discovery LS SystemSummary page 1…mography C. Prdct Devices: Siemens/CTI Accel -- CPS Innovations - K002584 GE Discovery LS - General Electric - K023988 D. Device Description: lmagcnPRO TM is a software application installed on desktop computers which allows physician… | 2003 |
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 |
|---|---|---|---|
| K173547 | ImagenUniversal | 2018 | 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 4 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K173547 (Cardiovascular Imaging Technologies, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K002584.
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 ImagenPROTM system is software that allows the user to visualize raw PET and/or PET/CT data, reconstruct myocardial perfusion PET or PET/CT images and reorient PET and/or PET/CT reconstructed tomograms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050366: Imagenpro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050366
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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