(9 days)
Not Found
No
The document describes standard image processing and fusion techniques for SPECT/CT systems and does not mention AI or ML.
No
This device is a gamma camera for imaging (SPECT), which is a diagnostic tool, not a therapeutic one. It produces images for anatomical localization and attenuation/scatter correction; it does not treat medical conditions.
Yes
Explanation: The device is a gamma camera for SPECT imaging, which produces images (both non-attenuation corrected and attenuation corrected SPECT images, and fused images with x-ray transmission data) to provide anatomical localization of nuclear medicine data. This process is used to obtain information about the body, which is a key characteristic of a diagnostic device.
No
The device description explicitly lists numerous hardware components, including a SPECT gantry, patient table, detectors, x-ray components, and an acquisition system, in addition to software.
Based on the provided information, this device 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.
- Device Function: The BrightView VCT is an imaging system that uses gamma rays (SPECT) and X-rays to create images of the inside of the body. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device as producing and processing images for anatomical localization and attenuation correction of nuclear medicine data. This is an in vivo (within the living body) imaging process, not an in vitro diagnostic test.
The device is a medical imaging system used for diagnostic purposes, but it falls under the category of medical devices that perform imaging on the patient, rather than analyzing samples from the patient.
N/A
Intended Use / Indications for Use
BrightView™ VCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. Bright View VCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the VCT images may be registered and displayed in a fused format (overlaid in the same ofientation) to provide anatomical localization of the nuclear medicine data. The BrightView VCT Imaging System should only be used by trained healthcare professionals.
Product codes
90 KPS
Device Description
BrightView VCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView VCT is defined as a low dose, high resolution SPECT/CT system with CT-like image quality used to perform attenuation correction and localization. The overall system includes the SPECT gantry, patient table, detectors for emission, flat panel xray detector for attenuation correction and localization, acquisition system, processing workstation, image processing/analysis and fusion software, and all other accessories required for the functionality of the system.
The BrightView VCT is designed to provide extended imaging functionality relative to a ring style gantry. It is designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes the gantry frame, display panel, two detectors, a collimator storage unit, an acquisition computer unit (with an optional customer desk), a patient imaging table (includes pallet catcher), and a hand controller. The patient imaging table (pallet) is mechanized for patient loading access and for movement during imaging studies. The table may be removed by the operator for imaging of patients in wheelchairs, beds, or gurneys. The pallet includes removable arm, leg/knee, shoulder and headrest supports for patient positioning during studies that require support. The flat panel x-ray detector can be folded into the gantry to accommodate collimator exchange or bed imaging.
The BrightView VCT is designed to allow acquisition of a broad range of imaging studies using single or dual detectors. When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate), BrightView VCT can be used to perform static, dynamic, gated, total body, circular-orbit and non-circular orbit SPECT studies, gated SPECT (circular and non-circular) studies. A flat panel x-ray detector and x-ray tube are mounted to the SPECT gantry to provide attenuation correction and localization capability.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Single Photon Emission Computed Tomography (SPECT), Flat Panel X-ray imaging components, CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals
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.
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PMS (Cleveland) Inc. BrightView VCT Imaging System CONFIDENTIAL
510(k) Premarket Notification Section B Administrative Information
510(k) SUMMARY SAFETY AND EFFECTIVENESS
APR 11 2008
Submitted By:
Philips Medical Systems (Cleveland), Inc. 540 Alder Dr. Milpitas, CA 95035
- B. Device Trade Name: Common Name: Classification Name: Device Class: Product Code:
Contact: Coleen A. Coleman Tel: (408) 468-3051 Fax: (408) 468-3050
BrightView™ VCT Imaging System Single Photon Emission Computed Tomography Emission Computed Tomography System 21CFR 892.1200, Class II 90 KPS
ে Date prepared: March 19, 2008
D. Predicate Devices: BrightView™ Gamma Camera System (K062298) GE 4 Option for Dual-Head Variable Angle Gamma Camera (K052434)
E. Intended Use:
BrightView™ VCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. Bright View VCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the VCT images may be registered and displayed in a fused format (overlaid in the same ofientation) to provide anatomical localization of the nuclear medicine data. The BrightView VCT Imaging System should only be used by trained healthcare professionals.
F. Device Description:
BrightView VCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView VCT is defined as a low dose, high resolution SPECT/CT system with CT-like image quality used to perform attenuation correction and localization. The overall system includes the SPECT gantry, patient table, detectors for emission, flat panel xray detector for attenuation correction and localization, acquisition system, processing workstation, image processing/analysis and fusion software, and all other accessories required for the functionality of the system.
The BrightView VCT is designed to provide extended imaging functionality relative to a ring style gantry. It is designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes the gantry frame, display panel, two detectors, a collimator storage unit, an acquisition computer unit (with an optional customer desk), a patient imaging table (includes pallet catcher), and a hand controller. The patient imaging table (pallet) is mechanized for patient loading access and for movement during imaging studies. The table may be removed by the operator for imaging of patients in wheelchairs, beds, or gurneys. The pallet includes removable arm, leg/knee, shoulder and headrest supports for patient positioning during studies that require
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support. The flat panel x-ray detector can be folded into the gantry to accommodate collimator exchange or bed imaging.
The BrightView VCT is designed to allow acquisition of a broad range of imaging studies using single or dual detectors. When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate), BrightView VCT can be used to perform static, dynamic, gated, total body, circular-orbit and non-circular orbit SPECT studies, gated SPECT (circular and non-circular) studies. A flat panel x-ray detector and x-ray tube are mounted to the SPECT gantry to provide attenuation correction and localization capability.
Technological Comparison: G.
The BrightView VCT, the BrightView system (K062298) and GE Hawkeye Infinia (K052434) predicate devices have similar intended use and indications for use. The SPECT portion of the Bright View VCT and the predicate Bright View SPECT are technologically equivalent. The Bright View VCT and the predicate Bright View have similar main mechanical and electrical components. All the SPECT features provided on the Bright View SPECT system are provided on the Bright View VCT. New features include:
- . A flat panel detector, x-ray tube and generator for volumetric CT transmission imaging for attenuation correction and localization.
- Change to the BrightView gantry to accommodate mounting of the x-ray imaging . components
- Acquisition software for attenuation correction and localization .
- Patient table to support 500 lb. load (227 kg) .
As stated above the Bright View VCT Gamma Camera System offers the following new features: attenuation correction and localization. The predicate Hawkeye Infinia offers similar SPECT features as well as attenuation correction and localization. The Hawkeye Infinia uses a dental x-ray tube with CT style detectors in a separate plane from the SPECT detectors. The BrightView VCT SPECT and X-ray detectors share a common imaging plane. The Bright View VCT and the Hawkeye Infinia have the x-ray components mounted to the SPECT gantry. The Hawkeye Infinia has a slip ring gantry while the Bright View VCT has a 9-axis ring gantry to provide similar capabilities.
H. Conclusion:
The BrightView VCT is substantially equivalent to the predicate devices BrightView (K062298) and GE Hawkeye Infinia (K052434) based upon identical indications for use, technological comparison and overall system performance.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract shapes stacked on top of each other, possibly representing human figures or a stylized flame.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems (Cleveland), Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Accredited Person Program Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131-1230
APR 11 2008
Re: K080927
Trade/Device Name: BrightView VCT Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: March 31, 2008 Received: April 2, 2008
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): 长 080927
Device Name:
BrightView VCT Imaging System
Indications For Use:
Bright View VCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView VCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the VCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView VCT Imaging System should only be used by trained healthcare professionals.
Prescription Use (Part 21 CFR 801 Subpart D) OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aomi Th Wh
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
ge 1 of
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