510(k) · Cleared
Recalled · 2008Pem 2400 Pet Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pem Technologies · KPS System, Tomography, Computed, Emission
Cleared on Aug 18, 2003 as substantially equivalent to K914267 (GE Medical Systems, 1992) and 2 other predicates after a 46-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 18, 2003
- Review
- 46 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K914267 (1992). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK914267 GE 4096 Plus & GE 2048GE Medical Systems · 1992
- This deviceK032063 Pem 2400 Pet ScannerPem Technologies · 2003
- Descendant · cites it directly · 1 of its ownK090553 Naviscan Pemflex Solo II High Resolution Pet ScannerNaviscan, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK214062 Radialis PET CameraRadialis, Inc. · 2022
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 |
|---|---|---|---|---|---|
| −1 | K914267 | GE 4096 Plus & GE 2048 | GE Medical Systems | 1992 | — |
| 0 (this device) | K032063 | Pem 2400 Pet Scanner | Pem Technologies | 2003 | — |
| +1 | K090553 | Naviscan Pemflex Solo II High Resolution Pet Scanner | Naviscan, Inc. | 2009 | — |
| +2 | K214062 | Radialis PET Camera | Radialis, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2022 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K914267 | GE 4096 Plus & GE 2048Summary page 1…1 CFR p2.1200. Device Manufacturing 5 1O(k) Number GE 2048 PET Scanner GE Medical Systems K9 14267 ECAT ART-LSO PET Scanner CTI PET Systems, Inc. KO0324 1 ECAT PETKT PET Scanner CTI PET… | 1992 |
| * | K003241 | Ecat Pet Scanner | 2000 |
| * | K002715 | Ecat Pet Scanner | 2000 |
| † | K991764 | Somatom Project 10-CT Scanners | 1999 |
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 |
|---|---|---|---|
| K090553 | Naviscan Pemflex Solo II High Resolution Pet Scanner | 2009 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 19, 2008 | Not classified | Z-2229-2008 | Device Design | This field correction is being initiated as a result of the firm's investigation into a report from a user indicating that the motorized compression exceeded 25 pounds of compression force during the pre-scan positioning of the patient.… |
| Aug 1, 2007 | Not classified | Z-0041-2008 | Software design | Naviscan has identified a potential safety issue with all versions of PEM View Software commonly used for analyzing patient images acquired on the PEMFIex product line. 1. The Positron Emission Mammography Standardized Uptake Value… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K090553 (Naviscan, Inc., 2009) has gone furthest, with 1 descendant 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.
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 PEM 2400 PET Scanner is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032063: Pem 2400 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/K032063
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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