510(k) · Cleared
Recalled · Class II · 2016Celesteion, Pca-9000A/2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshibamedical Systems Corporation · KPS System, Tomography, Computed, Emission
Cleared on Jun 11, 2014 as substantially equivalent to K123500 (Toshibamedical Systems Corporation, 2013) and 1 other predicate after a 90-day review. Its family tree reaches back 9 generations to 1993. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 11, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 9 generations to K930090 (1993). 29 ancestors in all, the oldest K903701 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
- 5 generations between
- 3 generations backK042935 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- 2 generations backK051170 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- 1 generation backK052640 Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- This deviceK140651 Celesteion, Pca-9000A/2Toshibamedical Systems Corporation · 2014
- Descendant · cites it directly · 1 of its ownK170490 Celesteion, PCA-9000A/3Toshibamedical Systems Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK181646 Celesteion, PCA-9000A/3, V6.5Canon Medical Systems Corporation · 2018
Show all 9 generations
- Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
- 8 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 7 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 6 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
- 4 generations backK041955 Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- 3 generations backK042935 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- 2 generations backK051170 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- 1 generation backK052640 Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- This deviceK140651 Celesteion, Pca-9000A/2Toshibamedical Systems Corporation · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −8 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −7 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −6 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −5 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
| −4 | K041955 | Gemini Pet/CT Imaging System | Philips Medical Systems (Cleveland), Inc. | 2004 | 2 |
| −3 | K042935 | Gemini GXL | Philips Medical Systems (Cleveland), Inc. | 2004 | 2 |
| −2 | K051170 | Gemini GXL | Philips Medical Systems (Cleveland), Inc. | 2005 | 12 |
| −1 | K052640 | Gemini Raptor | Philips Medical Systems (Cleveland), Inc. | 2005 | 36 |
| 0 (this device) | K140651 | Celesteion, Pca-9000A/2 | Toshibamedical Systems Corporation | 2014 | — |
| +1 | K170490 | Celesteion, PCA-9000A/3 | Toshibamedical Systems Corporation | 2017 | — |
| +2 | K181646 | Celesteion, PCA-9000A/3, V6.5 | Canon Medical Systems Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K123500 | Aquilion LB Triton V4.91Summary page 2…Number Clearance Date Aquilion LB Triton, V4.91 Toshiba America Medical Systems K123500 May 2, 2013 Gemini Raptor Philips Healthcare IK052640 IOctober 7,… | 2013 |
| * | K052640 | Gemini RaptorSummary page 2…e Aquilion LB Triton, V4.91 Toshiba America Medical Systems K123500 May 2, 2013 Gemini Raptor Philips Healthcare IK052640 IOctober 7, 2005 12. REASON FOR SUBMISSION: New device 13. DEVICE DESCRIPTION: Celestelan, PCA-9000A,… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170490 | Celesteion, PCA-9000A/3 | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2016 | Class II | Z-1607-2016 | Device Design | Potential degradation of detector performance. |
| May 8, 2015 | Class II | Z-0005-2016 | Device Design | It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 16 of the 29 ancestors have a recall of any class.
- Of its descendants, K170490 (Toshibamedical Systems Corporation, 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K123500.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT component produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET component images the distribution of PET radiopharmaceuticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT…
Read the full statement (142 words)
The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT component produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET component images the distribution of PET radiopharmaceuticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT images.
This device is to be used by a trained health care professional to gather metabolic and functional information from the distribution of the radiopharmaceutical in the body for the assessment of metabolic and physiologic functions. This information can assist in the evaluation, detection, diagnosis, therapeutic planning and therapeutic outcome assessment of (but not limited to) cancer, cardiovascular disease and brain dysfunction. Additionally, this device can be operated independently as a whole body multi-slice CT scanner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140651: Celesteion, Pca-9000A/2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140651
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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