(200 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware and software modifications for attenuation correction, not AI/ML processing.
No
The device is described as being used for "diagnostic imaging of organs and lesions" and is a modification of a "gamma camera system," which are inherently diagnostic tools, not therapeutic.
Yes
The device is explicitly stated to be used for "diagnostic imaging of organs and lesions" and indicates its use in "Nuclear Medicine diagnostic examinations."
No
The device description explicitly states that it includes adding hardware and software 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 an in vivo (within the living body) diagnostic procedure, not an in vitro (outside the living body) test.
- Device Description: The device is a modification of a "gamma camera system," which is used for nuclear medicine imaging. This is an imaging modality that involves administering a radioactive tracer to the patient and detecting the emitted gamma rays from within the body.
- Input Imaging Modality: The input modality is "gamma camera," which is an in vivo imaging technique.
IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the body to diagnose diseases or conditions. This device operates by imaging the patient directly.
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 STEP Option to the Prism Dual Head system is a modification of 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
Not Found
Anatomical Site
"of organs and lesions."
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"The STEP option 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
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 have shown that the STEP option has minimized the degrading effects of body attenuation when compared to a standard gamma camera without STEP correction. The product will perform in accordance with the development specifications."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
EP 2 0 1996
960865
PICKER INTERNATIONAL 510(k) NOTICE
STEP OPTION TO THE PRISM DUAL HEAD 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 513(f)(3) for the STEP for Prism Dual Head (system).
The STEP Option to the Prism Dual Head 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 STEP option to the Prism Dual Head system is substantially equivalent to legally marketed devices. The STEP option will be operated by trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations. The STEP option 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 have shown that the STEP option has minimized the degrading effects of body attenuation when compared to a standard gamma camera without STEP correction. The product will perform in accordance with the development specifications. A matrix was enclosed comparing the STEP option 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 STEP option. In addition, all information contained in this 510(k) Notice is accurate and complete.