(80 days)
No
The summary describes standard SPECT imaging and processing, and there is no mention of AI or ML in the device description, intended use, or processing software details.
No
The device is described as a "diagnostic imaging device" used to acquire and process images for depicting the anatomical distribution of radioisotopes, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The ClearVision nuclear medicine imaging system is intended for use as a diagnostic imaging device".
No
The device description explicitly details hardware components such as detectors, towers, a patient chair, rails, and lasers, indicating it is a physical imaging system that includes software for processing.
Based on the provided text, the ClearVision nuclear medicine imaging system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ClearVision's Function: The ClearVision system is described as a diagnostic imaging device. It acquires and processes SPECT images by detecting the distribution of radiopharmaceuticals within the patient's body. This is an in vivo (within the living organism) process, not an in vitro (in glass, or outside the body) process.
- No Mention of Samples: The description focuses on the imaging system, detectors, patient positioning, and image processing. There is no mention of collecting or analyzing biological samples from the patient.
Therefore, the ClearVision system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ClearVision nuclear medicine imaging system is intended for use as a diagnostic imaging device to acquire and process gated and non-gated Single Photon Emission Computed Tomography (SPECT) images.
Used with appropriate radiopharmaceuticals, the ClearVision system produces images that depict the anatomical distribution of radioisotopes within the myocardium.
Product codes
90 KPS
Device Description
The ClearVision Nuclear Medicine Imaging System acquires and processes cardiac data including gated and non-gated Single Photon Emission Computed Tomography (SPECT) studies. After completion of an acquisition, the operator can select the resulting acquisition data file to generate both qualitative and quantitative results for review by a physician. This includes processing using Release 5.6 of Segami Corporation's Mirage processing software that was previously cleared under 510(k) number K043441 dated 13-January-2005.
The acquisition system consists of either a single or dual small field-of-view detectors with each mounted on top of a tower that contains system electronics. To support the acquisition of SPECT data, the patient chair rotates up to 360 degrees in either clockwise or counterclockwise direction.
Prior to a patient scan, the following system features are used to ensure the myocardium is centered within each detector's field of view (FOV):
- . Each tower can be moved horizontally along rails mounted to the floor plate.
- . The patient chair seat pan can be moved side-to-side.
- Vertical and a horizontal beam lasers are mounted to side of detector.
The ClearVision system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Single Photon Emission Computed Tomography (SPECT)
Anatomical Site
myocardium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
B Administrative Information
OCT 2 5 2007
B.1 510(k) Summary of Safety and Effectiveness
Image /page/0/Picture/6 description: The image shows the logo of GVI Medical Devices, along with their address. The logo features an atom-like graphic with the letters "gvi" in a stylized font. Below the logo, the words "MEDICAL DEVICES" are printed in smaller letters. The address is "1470 Enterprise Parkway Twinsburg, OH 44087".
p. 330.963.4083
f. 330.963.4084
www.avimd.com
The following information is in accordance with 21 CFR 807.92.
- B.1.1 Submitted By:
Name and Address:
| Contact Person: | |
|---|---|
| Telephone: | |
| Fax: | |
| E-mail: | |
| Date Prepared: |
B.1.2 Device Identification
Trade / Proprietary Name: Common Name: Classification Name: 21 CFR Number: CDRH Product Code: Regulatory Device Class: Classification Panel:
GVI Medical Devices 1470 Enterprise Parkway Twinsburg, Ohio 44087 Kevin Murrock 330-963-4083, x113 330-963-4084 mailto:kevin.murrock@gvitp.com 3-August-2007
ClearVision Nuclear Imaging System SPECT System System, Emission Computed Tomography 892.1200 90 KPS ll Radiology
B.1.3 Predicate Device Manufacturer: Digirad Corporation Trade Name: Cardius 1 XPO and Cardius 2 XPO SPECT Imaging Systems 510(k) Number: K070542 CDRH Product Code: 90 KPS
1
B.1.4 Device Description
The ClearVision Nuclear Medicine Imaging System acquires and processes cardiac data including gated and non-gated Single Photon Emission Computed Tomography (SPECT) studies. After completion of an acquisition, the operator can select the resulting acquisition data file to generate both qualitative and quantitative results for review by a physician. This includes processing using Release 5.6 of Segami Corporation's Mirage processing software that was previously cleared under 510(k) number K043441 dated 13-January-2005.
The acquisition system consists of either a single or dual small field-of-view detectors with each mounted on top of a tower that contains system electronics. To support the acquisition of SPECT data, the patient chair rotates up to 360 degrees in either clockwise or counterclockwise direction.
Prior to a patient scan, the following system features are used to ensure the myocardium is centered within each detector's field of view (FOV):
- . Each tower can be moved horizontally along rails mounted to the floor plate.
- . The patient chair seat pan can be moved side-to-side.
- Vertical and a horizontal beam lasers are mounted to side of detector.
The ClearVision system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.
B.1.5 Intended Use
The ClearVision nuclear medicine imaging system is intended for use as a diagnostic imaging device to acquire and process gated and non-gated Single Photon Emission Computed Tomography (SPECT) images.
Used with appropriate radiopharmaceuticals, the ClearVision system produces images that depict the anatomical distribution of radioisotopes within the myocardium.
B.1.6 Substantial Equivalence Comparison
The ClearVision is of a comparable type and substantially equivalent to the Digirad Cardius 1 XPO and Cardius 2 XPO SPECT Imaging Systems (510(k) Number K070542), as both devices are used to acquire gated and non-gated SPECT studies using similar physical characteristics (refer to feature comparison summary table in Section B.1.7). In addition, the detector layout and electronics are identical in both physical and performance characteristics to the detector used on the GVI Medical Devices OnePass Nuclear Imaging System (510(k) K023373).
The primary difference between the ClearVision and the Cardius 1 and 2 XPO Systems is in detector technology and collimation. ClearVision uses traditional Anger technology detectors along with proprietary inverse fan-beam collimators, while the Cardius XPO systems use solidstate detectors and parallel-hole collimators. Refer to Attachment B for detailed description of the inverse fan-beam collimator.
2
| Feature | ClearVision | Cardius 1 and 2 XPO |
|---|---|---|
| Acquisition Types | SPECT and Gated SPECT | Same |
| Other Acquisition Types | None | Planar and Planar Gated |
| Number of Detectors | One or Two | One or Two |
| Detector Technology | Anger (33 photomultiplier tubes) | Solid-state |
| Crystal Material | Nal(TI) | Csi(TI) |
| Small Detector UFOV | Yes | |
| 8.5" x 8.5" UFOV | Yes | |
| 6.2" x 8.3" UFOV | ||
| Collimator | Inverse Fan-Beam | Parallel-Hole (LEHR) |
| NEMA Reconstructed Spatial | ||
| Resolution with Scatter | 9.8 mm (central) | |
| 7.6 mm (tangential) | ||
| 8.4 mm (radial) | 11.00 mm | |
| NEMA System Sensitivity | 147 cpm / uci | 160 cpm / uci |
| NEMA Energy Resolution | ≤ 9.0 % |