(88 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.
No
Explanation: The device is intended for diagnostic imaging and does not describe any therapeutic function.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to be used for diagnostic imaging of organs and lesions".
No
The device description explicitly states that it includes adding hardware and software to a gamma camera system, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "diagnostic imaging of organs and lesions." This describes a device used to visualize structures within the body, which is the domain of medical imaging, not in vitro diagnostics.
- Device Description: The device is a "new gantry for a gamma camera system." Gamma cameras are used for nuclear medicine imaging, which involves detecting radiation emitted from within the body after a radioactive tracer is administered. This is an in vivo process, not an in vitro process.
- Input Imaging Modality: The input is a "gamma camera system," further confirming its role in in vivo imaging.
In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform such tests.
N/A
Intended Use / Indications for Use
"This device is intended to be used for diagnostic imaging of organs and lesions."
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
"The Prism XPVT system is a new gantry for a gamma camera system. This device includes adding hardware and software to a gamma camera system."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma camera system
Anatomical Site
"diagnostic imaging of organs and lesions"
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations"
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"Laboratory tests will be run to validate the image quality performance of the system. The product will perform in accordance with the development specifications. A matrix was enclosed comparing the Prism XPVT to a predicate device and therefore we concluded that it is substantially equivalent to that legally marketed predicate device."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
KA64712
FEB 20 1997
PICKER INTERNATIONAL 510(k) NOTICE
PRISM XPVT SYSTEM
E: SUMMARY OF SAFETY AND EFFECTIVENESS
This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (DRAERD) of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 807.92(c) for the Prism XPVT system.
The Prism XPVT system is a new gantry for a gamma camera system. This device is intended to be used for diagnostic imaging of organs and lesions. There is no change of intended use from that of the predicate device. This device includes adding hardware and software to a gamma camera system.
Functional specifications and operator's instructions (preliminary) are included in the attachments. Final documentation will be provided with productions units.
The Prism XPVT system is substantially equivalent to legally marketed devices. The system will be operated by trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations. The Prism XPVT system will be certified to electrical safety standards (IEC-601 or UL-544) by a third party organization prior to use on human patients. Labeling (Product Bulletin and Operator's Manual) will be provided to the user of the equipment.
Laboratory tests will be run to validate the image quality performance of the system. The product will perform in accordance with the development specifications. A matrix was enclosed comparing the Prism XPVT to a predicate device and therefore we concluded that it is substantially equivalent to that legally marketed predicate device.
Picker has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the Prism XPVT. In addition, all information contained in this 510(k) Notice is accurate and complete.