(106 days)
GE Discovery IQ PET/CT system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
The system is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions in patients of all ages. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.
The system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems.
The Discovery™ IQ consists of a fully integrated 3D Positron Emission Tomography and multi-slice Computed Tomography scanner with all available CT diagnostic applications, except gantry tilt. The PET detector is scalable offering 2 through 5 detector rings. Due to the overall length of the PET/CT, the patient table sits on a special base that drives the table between the PET and CT portions of the gantry. The PET/CT table is rated for a patient weight of 227 Kg (500 pounds) and the cradle travels up to 1700mm on standard systems, or up 2 meters on systems with the 2m scan range option.
This document is a 510(k) premarket notification for a medical imaging device, the GE Discovery IQ PET/CT system. It does not describe acceptance criteria for an AI/ML device, nor does it present a study proving the device meets specific acceptance criteria in the context of AI/ML performance.
The document focuses on demonstrating substantial equivalence to a previously marketed device (Discovery PET/CT 710, K133657) under FDA regulations. This is a regulatory pathway for new devices that are similar enough to existing ones that they don't require the more extensive clinical trials needed for novel devices.
Therefore, I cannot provide the requested information from the given text because it is not present. The document discusses:
- Device Name: Discovery IQ
- Intended Use: PET/CT imaging for various medical assessments, including cancer, cardiovascular disease, and brain dysfunction, and radiotherapy planning. It can also be used as a stand-alone CT system.
- Regulatory Classification: Class II, Emission computed tomography system (21 CFR 892.1200), Product Code KPS.
- Comparison to Predicate Device: States that the Discovery IQ employs the same design, construction, materials, energy source, operating principles, and technology, and that reconstruction algorithms are identical to existing methods. It asserts that the Discovery IQ performs as well as predicate devices and has no significant change in safety or effectiveness.
None of the requested AI/ML specific information (acceptance criteria table, sample sizes for test/training, expert qualifications, ground truth types, MRMC studies, standalone performance) is detailed in this 510(k) summary because the device described is a conventional imaging system, not an AI/ML driven diagnostic tool in the sense of the prompt's requirements.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.