# K042428: SCEPTREP3 Pet/CT

- Pathway: 510(k) (Abbreviated)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Sep 17, 2004 after 9 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K944131 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040902: Hitachi Presto, Hitachi Medical Systems America, Inc. (2004) Summary page 1.
- K003241: Ecat Pet Scanner, Cti Pet Systems, Inc. (2000) Summary page 1.
- K023768: Ecat Pet/CT; Ecat Lso Pet/CT; Ecat Lso Pet/CT 16, Cti Pet Systems, Inc. (2002) Summary page 1.
- K021314: Sceptre-VS, Hitachi Medical Systems America, Inc. (2002) Summary page 1.

## Recalls of this device
- Feb 21, 2006 · Not classified · Z-1078-06: 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, whe
- Feb 21, 2006 · Not classified · Z-1079-06: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K042428
Methodology: https://510kreport.com/methodology