(61 days)
Not Found
No
The summary describes a standard CT scanner and does not mention any AI or ML capabilities in the intended use, device description, or other sections.
No
The device is described as an imaging system (Computed Tomography X-Ray System) intended to produce cross-sectional images for diagnostic purposes, not for treating diseases or conditions.
Yes.
The device's intended use is to produce cross-sectional images of the body for computer reconstruction, which is a key function of diagnostic imaging.
No
The device description explicitly states it is a "Whole Body Computed Tomography X-Ray System" which includes hardware components like an X-ray tube, detectors, gantry, patient supports, and accessories, in addition to signal analysis and display equipment. This is not a software-only device.
Based on the provided information, the "Brilliance Volume" is not an IVD (In Vitro Diagnostic) device.
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 is an in vivo imaging technique, meaning it examines the body directly.
- Device Description: The description reinforces that it's a Whole Body Computed Tomography X-Ray System that acquires x-ray transmission data from the body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
The "Brilliance Volume" operates by sending X-rays through the patient's body and detecting the transmission data, which is then used to create images. This is fundamentally different from the analysis of samples outside the body that characterizes IVD devices.
N/A
Intended Use / Indications for Use
The "Brilliance Volume" 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
90 JAK
Device Description
The "Brilliance Volume" is a Whole Body Computed Tomography 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 crosssectional 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
Not Found
Key Metrics
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.
0
Ko60937
JUN - 5 2006
510(k) Summary Philips Medical Systems (Cleveland) Inc. "Brilliance Volume"
This summary of this 510(k) provides safety and effectiveness information submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter
Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, OH 44143 (440) 483-3000
Contact:
| Robert L. Turocy | ||
|---|---|---|
| Telephone: | 440 483 3528 | |
| FAX: | 440 483 2989 | |
| Email: | Robert.Turocy@philips.com |
Date of Summary: April 1, 2006
2. Device Name and Classification
| Device Name: | Brilliance Volume |
|---|---|
| Classification Name: | Computed Tomography X-Ray System |
The FDA has classified the Computed Tomography X-Ray System and its accessories as Class II in 21 CFR 892.1750 (Product Code 90 JAK)
Predicate Device Information 3.
In the opinion of Philips Medical Systems Inc., the "Brilliance Volume" CT scanner is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely: the Philips Plus in K033326.
4. Device Description
The "Brilliance Volume" is a Whole Body Computed Tomography 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 crosssectional 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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5. Intended Use of the device
The "Brilliance Volume" 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.
6. Comparison to Predicate Devices
In the opinion of Philips Medical Systems (Cleveland), Inc., the "Brilliance Volume" CT scanner is of comparable type and substantially equivalent to the legally marketed devices because it has the similar technological characteristics and sub-assemblies as the current commercial distribution of Philips Plus (K033326).
The safety and effectiveness of the "Brilliance Volume" is assured by adherence to Good Manufacturing Practices (GMP) 21 CFR 820 and to International Standards ISO 13485:2003. Potential hazards are identified in a hazard analysis and controlled in the following manner:
Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures are adhered to, and meeting the specifications and functional requirements is demonstrated via testing.
Electrical and Mechanical safety is assured by adherence to IEC 60601-1 Standards,
Radiation safety is assured by compliance with 21 CFR, Subchapter J Performance Standards.
Based on the above considerations, it is Philips's opinion that the "Brilliance Volume" CT scanner is substantially equivalent in safety and effectiveness to the predicate device: Philips Plus with 510(k) Number K033326.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is black and white, providing a clear and recognizable emblem for the department.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN - 5 2006
Mr. Robert L. Turocy Regulatory & Approbation Manager Philips Medical Systems (Cleveland), Inc. Business Unit Computed Tomography 595 Miner Road CLEVELAND OH 44143
Re: K060937
Trade/Device Name: "Brilliance Volume" Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 1, 2006 Received: April 5, 2006
Dear Mr. Turocy:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a logo for the FDA Centennial, which is celebrating 1906-2006. The logo is circular and contains the letters FDA in the center. Below the logo, the words "Protecting and Promoting Public Health" are written in a decorative font.
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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 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" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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"Brilliance Volume" Device Name:
The "Brilliance Volume" is a Computed Indications for Use: 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Daniel h. Larson
(Division Sign-Off ivision of Reproductive, Abdominal and Radiological Devic 510(k) Number