510(k) · Cleared
ClearedPca-8000A, Mark 11, Pet / CT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · KPS System, Tomography, Computed, Emission
Cleared on Aug 21, 2008 as substantially equivalent to K050559 (GE Medical Systems, 2005) and 1 other predicate after a 13-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Aug 21, 2008
- Review
- 13 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K903701 (1990). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK903701 XpressToshiba America Medical Systems, In.C · 1990
- 4 generations backK982265 Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 1998 · Recalled
- 3 generations backK020385 CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 2002
- 2 generations backK022050 CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A…Toshiba America Medical Systems, In.C · 2002
- 1 generation backK050458 TSX-201A Aquilion LB CT ScannerToshiba America Medical Systems, In.C · 2005 · Recalled
- This deviceK082244 Pca-8000A, Mark 11, Pet / CT SystemToshiba America Medical Systems, In.C · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903701 | Xpress | Toshiba America Medical Systems, In.C | 1990 | — |
| −4 | K982265 | Aquilion CT Scanner, Model TSX-101A | Toshiba America Medical Systems, In.C | 1998 | 3 |
| −3 | K020385 | CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101A | Toshiba America Medical Systems, In.C | 2002 | — |
| −2 | K022050 | CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion… | Toshiba America Medical Systems, In.C | 2002 | — |
| −1 | K050458 | TSX-201A Aquilion LB CT Scanner | Toshiba America Medical Systems, In.C | 2005 | 1 |
| 0 (this device) | K082244 | Pca-8000A, Mark 11, Pet / CT System | Toshiba America Medical Systems, In.C | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K050559 | GE Discovery VCT SystemSummary page 1…21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard Predicate Device(s): GE Discovery VCT; K050559 Toshiba, TSX-201A, Aquilion LB K050458 Reason for Submission New Device Dev… | 2005 |
| * | K050458 | TSX-201A Aquilion LB CT ScannerSummary page 1…l Diagnostic X-ray Equipment Standard Predicate Device(s): GE Discovery VCT; K050559 Toshiba, TSX-201A, Aquilion LB K050458 Reason for Submission New Device Device Description: The PCA-8000A consists of an integrated multi-slice CT syst… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
- 7 of the 12 ancestors have a recall of any class.
- 2 other devices also cite its predicate K050559.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
This device is intended to acquire PET images of any desired region of the whole body simultaneously with CT images of the same region (to be used for attenuation correction or image fusion), to detect the location of a positron emitting radiopharmaceutical in the body with obtained 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…
Read the full statement (121 words)
This device is intended to acquire PET images of any desired region of the whole body simultaneously with CT images of the same region (to be used for attenuation correction or image fusion), to detect the location of a positron emitting radiopharmaceutical in the body with obtained 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 research, diagnosis, therapeutic planning and therapeutic outcome assessment of (but not limited to) dancer, cardiovascular disease and brain dysfunction. Additionally, this device can function independently as a whole body multi-slice CT scanner
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082244: Pca-8000A, Mark 11, Pet / CT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082244
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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