Discovery ST PET/CT Imaging System With Alternate Detector

• • Terminated Z-0588-06 FDA Unclassified (pre-2012) ·initiated 26 Jan 2006

  The LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system.

Full name

Discovery St Pet/CT Imaging System with an Alternate Detector Option

510(k) Number

K042257 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What clinical applications is the Discovery ST PET/CT Imaging System primarily designed for?

  The Discovery ST PET/CT Imaging System is designed for whole-body attenuation-corrected Positron Emission Tomography (PET) imaging and integrated PET-CT scans. This combination allows for precise localization of emission activity within patient anatomy, aiding in diagnostic evaluations such as oncology (cancer detection and staging), cardiology (assessing blood flow and viability), and neurology (evaluating brain function). The integrated imaging helps correlate metabolic activity with anatomical structures.

• Is the Discovery ST PET/CT Imaging System a single-use or reusable device, and how should it be maintained?

  The Discovery ST PET/CT Imaging System is explicitly described as a reusable medical device. Since it is not disposable, proper maintenance and cleaning protocols must be followed as outlined in General Electric’s operational guidelines to ensure reliability, accuracy, and infection control. Maintenance includes regular servicing, calibration, and adherence to manufacturer-recommended cleaning procedures for the imaging components.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for buyers?

  The Discovery ST PET/CT Imaging System received FDA 510(k) clearance under Special Controls for Class II devices, with a decision described as *Substantially Equivalent* to a predicate device. This means the FDA determined it met established safety and performance criteria for hybrid PET/CT systems, including compliance with radiology-specific guidelines. Buyers should confirm the device’s product code (KPS) and registration numbers in the FDA database to verify its regulatory status and ensure it aligns with their facility’s requirements for imaging technology.

• Does the system include any optional configurations, and if so, what are they?

  Yes, the Discovery ST PET/CT Imaging System features an alternate detector option, which likely refers to interchangeable or upgradeable detector components to enhance imaging performance or adapt to specific clinical needs. This flexibility may include variations in detector sensitivity, field of view, or compatibility with different imaging protocols. Buyers should consult General Electric’s technical documentation to confirm the exact specifications and compatibility of the alternate detector options with their intended use.

• How should the Discovery ST PET/CT Imaging System be stored to preserve its functionality?

  While the provided data does not specify storage conditions in detail, reusable medical imaging systems like this typically require protection from environmental factors such as extreme temperatures, humidity, and physical damage. Storage should follow General Electric’s operational manual, which likely includes guidelines for covering components, securing cables, and maintaining a clean environment to prevent contamination or degradation of performance. Proper storage ensures longevity and reliability of the system.