(90 days)
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No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as being used for "diagnostic imaging," which indicates it is for diagnosis, not therapy.
Yes
The intended use explicitly states, "This device is intended to be used for diagnostic imaging of organs and lesions." It also mentions "Nuclear Medicine diagnostic examinations" in the intended user description.
No
The device description explicitly states that it includes both hardware and software modifications to a gamma camera system.
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 characteristic of in vivo diagnostic imaging, not in vitro (outside the body) testing of samples.
- Device Description: It's a modification of a gamma camera system, which is a medical imaging device used to detect radiation emitted from a radioactive tracer administered to a patient. This is an in vivo process.
- Input Imaging Modality: "gamma camera" confirms it's an imaging device used on a living patient.
IVD devices are typically used to examine samples taken from the body (like blood, urine, tissue) to diagnose conditions. This device operates by imaging the patient directly.
N/A
Intended Use / Indications for Use
The Prism 3000XPV system is a modification of 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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Prism 3000XPV system is a modification of 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
organs and lesions
Indicated Patient Age Range
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Intended User / Care Setting
will be operated by trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 3000XPV 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.
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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.
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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).
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§ 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
K961577 JUL 23 1996
PICKER INTERNATIONAL 510(k) NOTICE
PRISM 3000XPV 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 3000XPV system.
The Prism 3000XPV system is a modification of 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 3000XPV 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 3000XPV system will be certified to electrical safety standards (IEC-601or 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 3000XPV 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 3000XPV. In addition, all information contained in this 510(k) Notice is accurate and complete.