# K051351: Precedence Spect/CT Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Jun 8, 2005 after 15 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930090 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041218: Griffin Spect/CT Imaging System, Adac Laboratories (2004) Summary page 1.
- K033326: Philips Plus Computed Tomography System, Philips Medical Systems, Inc. (2003) Summary page 1.
- K042293: Brilliance CT, Private Practice CV Configuration, CT Scanner, Philips Medical Systems (Cleveland), Inc. (2004) Summary page 1.

## Recalls of this device
- Jan 26, 2009 · Not classified · Z-0897-2011: A problem has been identified with some upper patient pallets on Precedence SPECT/CT System, which may reduce its load bearing capacity and may result in its cracking. If this were to happens, could p

## Indications for use
Precedence is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The x-ray computed tomography subsystem may consist of a whole body multi-slice CT or cardiovascular CT. The cardiovascular subsystem provides coronary imaging that is intended to produce cross-sectional images of the heart, cardiovascular, and peripheral vascular systems by computer reconstruction of x-ray transmission data taken at difference angles and planes. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals. The Precedence CV Configuration CT subsystem is only for the imaging of the cardiovascular system.

Source page: https://510kreport.com/device/K051351
Methodology: https://510kreport.com/methodology