# K140651: Celesteion, Pca-9000A/2

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jun 11, 2014 after 90 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: 9 generations back to K930090 (1993). 29 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123500: Aquilion LB Triton V4.91, Toshibamedical Systems Corporation (2013) Summary page 2.
- K052640: Gemini Raptor, Philips Medical Systems (Cleveland), Inc. (2005) Summary page 2.

## Most influential descendants
- K170490: Celesteion, PCA-9000A/3 (2017), 1 descendant of its own
- K181646: Celesteion, PCA-9000A/3, V6.5 (2018), 0 descendants of its own

## Recalls of this device
- Apr 24, 2016 · Class II · Z-1607-2016: Potential degradation of detector performance.
- May 8, 2015 · Class II · Z-0005-2016: It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.

## Indications for use
The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT component produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET component images the distribution of PET radiopharmaceuticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT 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 evaluation, detection, diagnosis, therapeutic planning and therapeutic outcome assessment of (but not limited to) cancer, cardiovascular disease and brain dysfunction. Additionally, this device can be operated independently as a whole body multi-slice CT scanner.

Source page: https://510kreport.com/device/K140651
Methodology: https://510kreport.com/methodology