(203 days)
No
The summary describes standard PET imaging technology and reconstruction algorithms, with no mention of AI or ML.
No.
The device is used for imaging (diagnosis), not for treating conditions.
Yes
The device produces images that depict the anatomical distribution of radioisotopes for interpretation by medical clinicians, indicating its use in diagnosing conditions based on these images.
No
The device is described as an "accessory upgrade" to existing hardware (VISION FX-80 Gamma Camera and Power Station) and explicitly mentions utilizing "proprietary coincidence detection electronics" in addition to software. This indicates it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "produce images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians." This describes an in vivo imaging device, where the radioisotope is administered to the patient and the device detects emissions from within the living body.
- Device Description: The description details a "Gamma Camera and Power Station" with an accessory for "positron emission tomography (PET) of radioisotopes within the human body." This further confirms it's an imaging system used on a living patient.
- IVD Definition: 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 tests on such samples.
The device is clearly an in vivo medical imaging device used for nuclear medicine procedures.
N/A
Intended Use / Indications for Use
The VCAR option to the VISION FX-80 Gamma Camera and Power Station produces images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The system is intended for whole body nuclear imaging.
Product codes (comma separated list FDA assigned to the subject device)
90 KPS
Device Description
The VCAR option to the VISION FX-80 Gamma Camera and Power Station (FX-80&PS/VCAR) is an accessory upgrade to the previously cleared FX-80 Gamma Camera (K935273) and Power Station (K912753). This accessory enables the system to perform electronic collimation for positron emission tomography (PET) of radioisotopes within the human body. The FX-80&PS/VCAR utilizes proprietary coincidence detection electronics and software to perform electronic collimation of gamma rays emitted from decay of radioisotopes in a patient. This process is called "Coincident Photon Emission Computed Tomography" (CPECT).
The FX-80&PS/VCAR allows the operator to acquire coincidence imaging data by controlling the detector electronics and processors in coincidence imaging mode. The FX-80&PS/VCAR also includes the control, processing, and display screens to perform reconstruction of 2-D and 3-D information from the acquired datasets.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET) - Coincident Photon Emission Computed Tomography (CPECT)
Anatomical Site
whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical clinicians
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)
Major performance parameters have been measured using industry-standard test methods to determine that the device meets its system performance specifications and performs in a fashion similar to predicate devices.
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.
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
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
K96.3273
Appendices Page 45 of 48
510(k) Summary Appendix X: MAR 1 1 1997 of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
August 20, 1996 Prepared:
- Submitter: SMV America 8380 Darrow Rd. Twinsburg, Ohio 44087 (800) 664-0844
- W. K. McCroskey Contact: Director of CPECT Imaging
| Device: | Classification Name: | System, Emission Computed Tomography | |
|---|---|---|---|
| Classification Number: | 90 KPS | ||
| Common or Usual Name: | Coincidence Imaging Gamma Camera | ||
| System | |||
| Trade/Proprietary Name: | VCAR option to VISION FX-80 Gamma | ||
| Camera and Power Station |
Predicate Devices:
| SPONSOR | PRODUCT | Preamendment
Status or 510(k)
Number |
|------------------------------|----------------------------------------|--------------------------------------------|
| UGM Medical Systems,
Inc. | Penn-PET
(marketed as GE Quest 300) | K930428 |
| ADAC Laboratories | MCD option to VERTEX Epic
System | K952684 |
1
Device Description Summary:
The VCAR option to the VISION FX-80 Gamma Camera and Power Station (FX-80&PS/VCAR) is an accessory upgrade to the previously cleared FX-80 Gamma Camera (K935273) and Power Station (K912753). This accessory enables the system to perform electronic collimation for positron emission tomography (PET) of radioisotopes within the human body. The FX-80&PS/VCAR utilizes proprietary coincidence detection electronics and software to perform electronic collimation of gamma rays emitted from decay of radioisotopes in a patient. This process is called "Coincident Photon Emission Computed Tomography" (CPECT).
The FX-80&PS/VCAR allows the operator to acquire coincidence imaging data by controlling the detector electronics and processors in coincidence imaging mode. The FX-80&PS/VCAR also includes the control, processing, and display screens to perform reconstruction of 2-D and 3-D information from the acquired datasets.
Intended Use:
The VCAR option to the VISION FX-80 Gamma Camera and Power Station produces images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The system is intended for whole body nuclear imaging.
Technological Characteristics:
The FX-80&PS/VCAR has been designed to perform imaging of PET isotopes in a way which is very similar to traditional PET systems (e.g., the GE Quest 300) and gamma camera PET systems (e.g., ADAC's MCD option to the VERTEX Epic System). The FX-80&PS/VCAR is very similar to both predicate devices.
Each system detects radioisotope emissions from the human body and integrates the acquired emission data over time to produce an image representing a quantification of emissions from the imaged region. All three units utilize the same theory of operation.
In all three systems, detection events from opposing detectors are compared, to determine if both detected an event almost simultaneously. Coincident events undergo
2
additional processing to generate images which show the frequency of annihilation events due to radioisotopes in the area being imaged.
Each of the three systems have additional post-acquisition processing systems which further manipulate the image data to perform 2-dimensional and 3 dimensional reconstructions of the imaged area.
In addition, all three systems are able to utilize any FDA-approved positron-emitting radioisotope (e.g., Fluorodeoxyglucose [FDG] ) to generate images.
Summary of Testing:
Major performance parameters have been measured using industry-standard test methods to determine that the device meets its system performance specifications and performs in a fashion similar to predicate devices.
Conclusion:
The VCAR option for the VISION FX-80 Gamma Camera and Power Station was developed and validated in accordance with the Company's product and software development procedures. System testing and validation demonstrates that the system meets its published specifications, performs as well as or better than the currently marketed product, and is safe and effective for its intended use.