510(k) · Cleared
Recalled · 2006SCEPTREP3 Pet/CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Sep 17, 2004 as substantially equivalent to K040902 (Hitachi Medical Systems America, Inc., 2004) and 3 other predicates after a 9-day review. Its family tree reaches back 6 generations to 1995. It has been recalled 2 times.
- Decided
- Sep 17, 2004
- Review
- 9 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 6 generations to K944131 (1995). 16 ancestors in all, the oldest K920950 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 5 generations backK964890 Anatom 2000Analogic Corp. · 1997
- 4 generations backK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
- 3 generations backK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
- 2 generations backK014240 ProntoHitachi Medical Systems America, Inc. · 2002
- 1 generation backK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
- This deviceK042428 SCEPTREP3 Pet/CTHitachi Medical Systems America, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −5 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| −4 | K982631 | Philips Tomoscan CS | Philips Medical Systems, Inc. | 1998 | — |
| −3 | K991278 | Philips Tomoscan AV-NT | Philips Medical Systems North America, Inc. | 1999 | — |
| −2 | K014240 | Pronto | Hitachi Medical Systems America, Inc. | 2002 | — |
| −1 | K040902 | Hitachi Presto | Hitachi Medical Systems America, Inc. | 2004 | 4 |
| 0 (this device) | K042428 | SCEPTREP3 Pet/CT | Hitachi Medical Systems America, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K040902 | Hitachi PrestoSummary page 1…Number: Sec. 892.1750 Sec. 892.1200 Predicate Devices Predicate Devices: Presto CT Ifitachi Medical K040902 ECAT EMERGE PET CTI PET Systems K003241I PET/CT Patient ifan… | 2004 |
| * | K003241 | Ecat Pet ScannerSummary page 1…ate Devices Predicate Devices: Presto CT Ifitachi Medical K040902 ECAT EMERGE PET CTI PET Systems K003241I PET/CT Patient ifandling System (PHS) CTI PET Systems K0… | 2000 |
| * | K023768 | Ecat Pet/CT; Ecat Lso Pet/CT; Ecat Lso Pet/CT 16Summary page 1…T CTI PET Systems K003241I PET/CT Patient ifandling System (PHS) CTI PET Systems K023768 Sceptre-VS (AVIA) Workstation Hitachi Medical K02 1314… | 2002 |
| * | K021314 | Sceptre-VSSummary page 1…(PHS) CTI PET Systems K023768 Sceptre-VS (AVIA) Workstation Hitachi Medical K02 1314 ©D2004 Hitachi Medical Systems America, Inc. SceptreP3 PET/CT Section 2… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 21, 2006 | Not classified | Z-1078-06 | Other | The device has a software anomaly which affects the system's ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, when MPR was run on them. |
| Feb 21, 2006 | Not classified | Z-1079-06 | Other | The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 16 ancestors have a recall of any class.
- 3 other devices also cite its predicate K040902.
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 SceptreP3 system is intended to be used:
1) to produce cross-sectional images of the human body that measure the distribution of positron emitting radiopharmaceuticals within the imaged area,
2) to produce cross-sectional images of the body produced by x-ray transmission from the same axial plane taken at different angles,
3) to create attenuation maps from the x-ray data to correct the PET images, and
4) to combine (co-register) the CT and PET images after reconstruction to produce images with both anatomical and physiological data.
The system processes, displays, and stores the reconstructed images. The device output can provide an aid to diagnosis when used by a qualified physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042428 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042428: SCEPTREP3 Pet/CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042428
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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