(99 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard CT technology and image reconstruction.
No
The device is a diagnostic imaging system used to produce cross-sectional images, not to treat or alleviate a disease or condition.
Yes
The device is described as producing "cross-sectional images of the body" and the performance studies mention "images... of diagnostic quality," indicating its use in diagnosing medical conditions.
No
The device description explicitly states it is a "Computed Tomography X-Ray System" with a "continuously rotating x-ray tube and detectors gantry," which are hardware components. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Computed Tomography X-Ray System intended to produce cross-sectional images of the body". This describes an imaging device used to visualize internal structures of the body.
- Device Description: The description further elaborates on how the device works by acquiring and reconstructing x-ray transmission data to create images of the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not perform any such analysis of specimens.
The Brilliance iCT is a medical imaging device used for diagnostic purposes, but it falls under the category of in vivo imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment; patient and equipment supports; components; and accessories.
Product codes
JAK
Device Description
The Brilliance iCT is a Whole Body Computed Tomography (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray transmission data
Anatomical Site
body
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)
The following tests demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004:
- CT Number, Uniformity, Noise and Tomographic Section Thickness Measurements
- CTD! Dose Measurements
- Air Dose Measurements
- Spatial Resolution Measurements
- Low Contrast Detectability Measurements
Clinical evaluation demonstrated that images, which are reconstructed by the modified system, have been evaluated by a radiologist as being of diagnostic quality.
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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510(k) Summary
Brilliance iCT
510(k) Number K131773
Applicant's Name:
Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, Ohio 44143
SEP 2 4 2013
Contact Person:
Catherine M. Connell Requlatory Affairs Specialist Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143 USA +1 440 483 5581 Tel: +1 440 483 4918 Fax: E-mail: catherine.connell@philips.com
Trade Name:
Brilliance iCT
Preparation Date:
July 09, 2013
Classification:
Name: System, X-Ray, Tomography, Computed Product Code: JAK Regulation No: 21 CFR 892.1750 Class: !! Panel: Radiology
Device Description:
The Brilliance iCT is a Whole Body Computed Tomography (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories.
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Intended Use Statement:
The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment; patient and equipment supports; components; and accessories.
Predicate Device:
Substantial equivalence to the following predicate device is claimed:
| Device Name | 510(k) No. | Date of Clearance |
|---|---|---|
| Brilliance Volume | K060937 | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | June 5, 2006 |
Compliance with Standards:
Brilliance iCT complies with the following standards:
- AAMI / ANSI ES 60601-1:2005/C1:2009 (R)2012, Medical . electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2:2007 (Ed. 3), Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-3:2008 (Ed. 2), Medical electrical equipment -. Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
- IEC 60601-2-44:2009 (Ed. 3), Medical electrical equipment. . Particular requirements for the basic safety and essential performance of X-rav equipment for computed tomography.
- . IEC 61223-3-5:2004 (Ed. 1), Evaluation and routine testing in medical imaging departments – Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment.
The system complies with performance standards for Computed Tomography (CT) Equipment and Laser products (21 CFR 1020.33 and 21 CFR 1040.10, respectively).
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Technical characteristics in comparison to predicate:
Both the cleared Brilliance iCT and its predicate device consist of :
- Operator station .
- Gantry .
- Patient table .
- Patient supports (positioning aids) .
The difference between the modified Brilliance iCT and its previously cleared predicate is:
- Modified detection array that maintains the same structure of t . 672 x 128 detectors
Substantial Equivalence:
The modified Brilliance iCT is a modification of its predicate device, the "Brilliance Volume". Both are Whole Body Computed Tomography (CT) X-Ray Systems, featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability, to reconstruct cross-sectional images from the acquired x-ray transmission data.
The modified Brilliance iCT and the legally marketed Brilliance iCT have the same intended use and use the same technology as the predicate device. The modifications that were made are to the detection array and in the supporting software. .
The safe and effective performance of the modified Brilliance iCT has been clearly demonstrated by bench tests.
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Image /page/3/Picture/0 description: The image shows the text "K131773 page 484" in a handwritten style. The text is black and appears to be written with a pen or marker. The text is slightly slanted to the right. The text is likely a reference number or page number for a document.
Performance Data:
The following tests demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004:
- . CT Number, Uniformity, Noise and Tomographic Section Thickness Measurements
- . CTD! Dose Measurements
- Air Dose Measurements .
- Spatial Resolution Measurements .
- Low Contrast Detectability Measurements .
Clinical evaluation demonstrated that images, which are reconstructed by the modified system, have been evaluated by a radiologist as being of diagnostic quality.
Conclusion:
Philips Medical Systems (Cleveland), Inc. believes that, based on the information provided in this submission, the modified Brilliance iCT is substantially equivalent to its predicate device without raising any new safety and/or effectiveness concerns.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, rendered in black lines. The figure is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24, 2013
Philips Medical Systems (Cleveland) Inc. % Ms. Catherine M. Connell Regulatory Affairs Specialist 595 Miner Road CLEVELAND OH 44143
Re: K131773
Trade/Device Name: Brilliance iCT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 22, 2013 Received: August 27, 2013
Dear Ms. Connell:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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Page 2 - Ms. Catherine M. Connell
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sm.h.7).
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K 131773
Device Name: Brilliance iCT
Indications for Use:
The "Brilliance iCT" is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components, and accessories.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (Part 21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
$(m,n,7)$
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K131773 510(k)
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