# K082244: Pca-8000A, Mark 11, Pet / CT System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Aug 21, 2008 after 13 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K903701 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050559: GE Discovery VCT System, GE Medical Systems (2005) Summary page 1.
- K050458: TSX-201A Aquilion LB CT Scanner, Toshiba America Medical Systems, In.C (2005) Summary page 1.

## Indications for use
This device is intended to acquire PET images of any desired region of the whole body simultaneously with CT images of the same region (to be used for attenuation correction or image fusion), to detect the location of a positron emitting radiopharmaceutical in the body with obtained 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 research, diagnosis, therapeutic planning and therapeutic outcome assessment of (but not limited to) dancer, cardiovascular disease and brain dysfunction. Additionally, this device can function independently as a whole body multi-slice CT scanner

Source page: https://510kreport.com/device/K082244
Methodology: https://510kreport.com/methodology