510(k) · Cleared
ClearedBBX-PET Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prescient Imaging, LLC · KPS System, Tomography, Computed, Emission
Cleared on Mar 17, 2021 as substantially equivalent to K091269 (Photodetection Systems, Inc., 2009) after a 29-day review. Its family tree reaches back 1 generation to 2009. 4 later devices descend from it.
- Decided
- Mar 17, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091269 (2009). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK091269 NeuropetPhotodetection Systems, Inc. · 2009
- This deviceK210450 BBX-PET ScannerPrescient Imaging, LLC · 2021
- Descendant · cites it directly · 0 of its ownK250170 PharosBrightonix Imaging · 2025
- Descendant · cites it directly · 0 of its ownK241751 NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF SeatPositrigo AG · 2024
- Descendant · cites it directly · 0 of its ownK240827 SET-5002Shimadzu Corporation Medical Systems Division · 2024
- Descendant · cites it directly · 0 of its ownK232569 CaremibrainGeneral Equipment For Medical Imaging, S.A. · 2023
Most influential descendants
Showing 4 of 4 · See all- K250170PharosBrightonix Imaging · 2025 · cites it directly0descendants
- K241751NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF SeatPositrigo AG · 2024 · cites it directly0descendants
- K240827SET-5002Shimadzu Corporation Medical Systems Division · 2024 · cites it directly0descendants
- K232569CaremibrainGeneral Equipment For Medical Imaging, S.A. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K091269 | Neuropet | Photodetection Systems, Inc. | 2009 | — |
| 0 (this device) | K210450 | BBX-PET Scanner | Prescient Imaging, LLC | 2021 | — |
| +1 | K250170 | Pharos | Brightonix Imaging | 2025 | — |
| +1 | K241751 | NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat | Positrigo AG | 2024 | — |
| +1 | K240827 | SET-5002 | Shimadzu Corporation Medical Systems Division | 2024 | — |
| +1 | K232569 | Caremibrain | General Equipment For Medical Imaging, S.A. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K091269 | NeuropetSummary page 4…KPS III. IDENTIFICATION OF PREDICATE DEVICE Predicate Device NeuroPET 510(k) number: K091269 Applicant: PhotoDetection Systems, Inc. This predicate has not been subject to… | 2009 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K250170 (Brightonix Imaging, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
BBXT™-PET scanner is intended to obtain positron emission tomography (PET) images of parts of the human body that fit in the patient aperture (e.g., head) to detect abnormal pattern of distribution of radioactivity after injection of a positron emitting radiopharmaceutical. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210450: BBX-PET Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210450
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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