(120 days)
No
The summary describes a standard CT system with a dual energy option, focusing on image acquisition and reconstruction based on physical principles of x-ray attenuation. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions, training sets, or performance studies related to AI/ML.
No.
The device is described as an X-Ray System intended to produce cross-sectional images for diagnostic purposes, not for treating a disease or condition. The "Intended Use" section explicitly states its purpose is to "produce cross-sectional images of the body by computer reconstruction of x-ray transmission data," which indicates a diagnostic function.
Yes
The device is a Computed Tomography X-Ray System that produces images of the body, and the text states it allows for the "visualization and analysis of anatomical and pathological materials," indicating its use in diagnosing conditions.
No
The device description explicitly states it is an option on a "Computed Tomography X-Ray System" and includes components like "signal analysis and display equipment, patient, and equipment supports, components and accessories," which are hardware elements.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Brilliance CT is a Computed Tomography X-Ray System. It uses 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 clearly states it's for producing cross-sectional images of the body.
- Device Description: The description focuses on the imaging process and the analysis of image data, not the analysis of biological samples.
Therefore, based on the provided information, the Brilliance CT is an imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Brilliance CT 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.
The dual energy option allows the system to acquire two CT images of the same anatomical location using two distinct tube voltages and/or tube currents during two tube rotations. The x-ray dose will be the sum of the doses of each tube rotation at its respective tube voltage and current. Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in x-ray attenuation between these distinct energies. This information may also be used to reconstruct images at multiple energies within the available spectrum, and to reconstruct basis images that allow the visualization and analysis of anatomical and pathological materials.
Product codes
90 JAK
Device Description
Philips Healthcare offers a Dual Energy scanning option on the Brilliance CT Scanner. The Brilliance Dual Energy option automates the execution of sequential scanning protocols acquired during the same episode of care using two unique tube voltages and/or currents. The acquired datasets can be displayed side-by-side or overlaid and then analyzed to augment the review of anatomical and pathological structures. Dual energy imaging, by nature of differing x-ray energy values, enables the identification of attenuation differences found in those structures between the two applied energies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-Ray System
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)
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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K09c462
Page 1 of 2
510(k) Summary Philips Medical Systems (Cleveland) Inc. Brilliance Dual Energy option
This summary of this 510(k) provides safety and effectiveness information submitted in accordance with the requirements of 21 CFR 807.92.
Submitter 1.
Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, OH 44143 (440) 483-3000
Contact:
| Michael A. Chilbert, Ph.D., P.E. | |
|---|---|
| Telephone: | 440 483-3284 |
| FAX: | 440 483 2989 |
| Email: | Michael.Chilbert@philips.com |
Date of Summary: January 7, 2009
Device Name and Classification 2.
| Device Name: | Brilliance Dual Energy option |
|---|---|
| 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)
3. Predicate Device Information
In the opinion of Philips Medical Systems Inc., the Brilliance Dual Energy option is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely: the Philips Brilliance Volume - K060937 and the GE Lightspeed CT750 HD - K081105.
4. Device Description
Philips Healthcare offers a Dual Energy scanning option on the Brilliance CT Scanner. The Brilliance Dual Energy option automates the execution of sequential scanning protocols acquired during the same episode of care using two unique tube voltages and/or currents. The acquired datasets can be displayed side-by-side or overlaid and then analyzed to augment the review of anatomical and pathological structures. Dual energy imaging, by nature of differing x-ray energy values, enables the identification of attenuation differences found in those structures between the two applied energies.
JUN 2 3 2009
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K09c462
Page 2 of 2
Intended Use of the device 5.
The Brilliance CT is a Computed Tomography X-Ray System intended to produce crosssectional 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.
The dual energy option allows the system to acquire two CT images of the same anatomical location using two distinct tube voltages and/or tube currents during two tube rotations. The x-ray dose will be the sum of the doses of each tube rotation at its respective tube voltage and current. Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in xray attenuation between these distinct energies. This information may also be used to reconstruct images at multiple energies within the available spectrum, and to reconstruct basis images that allow the visualization and analysis of anatomical and pathological materials.
Comparison to Predicate Devices 6.
In the opinion of Philips Medical Systems (Cleveland), Inc., the Brilliance CT scanner with Dual Energy option is of comparable type and substantially equivalent to the legally marketed devices because it has the similar technological characteristics and subassemblies as the current commercial distribution of Philips Brilliance Volume (K060937) and the GE Lightspeed CT750 HD (K081105).
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2009
Michael Chilbert, Ph.D., P.E. Quality & Regulatory Engineer Philips Medical Systems (Cleveland), Inc. 595 Miner Road CLEVELAND OH 44143
Re: K090462
Trade/Device Name: Brilliance Dual Energy option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 5, 2009 Received: June 9, 2009
Dear Dr. Chilbert:
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 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 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
3
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrlv/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.lttml.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
KO90462
Page 1 of 1
Device Name:
Brilliance Dual Energy option
The Brilliance CT is a Computed Tomography X-Ray Indications for Use: 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,
The dual energy option allows the system to acquire two CT images of the same anatomical location using two distinct tube voltages and/or tube currents during two tube rotations. The x-ray dose will be the sum of the doses of each tube rotation at its respective tube voltage and current. Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in x-ray attenuation between these distinct energies. This information may also be used to reconstruct images at multiple energies within the available spectrum, and to reconstruct basis images that allow the visualization and analysis of anatomical and pathological materials.
Prescription Use (Part 21 CFR 801 Subpart D) AND/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)ivision of Reproductive. Abdomin: and Radiological Devi 510(k) Number