(15 days)
Not Found
No
The document describes standard CT image reconstruction and signal analysis, with no mention of AI, ML, or related concepts.
No.
The device is used to produce images for diagnostic purposes, not to provide treatment or therapy.
Yes
The device is described as producing images which are then reconstructed by computer into cross-sectional images for diagnostic purposes, in this case, of the heart, cardiovascular, and peripheral vascular systems.
No
The device description explicitly states it is a "Computed Tomography X-Ray System" featuring hardware components like an X-ray tube, detectors, and gantry, in addition to software for reconstruction and display.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The Philips Brilliance CT system described here is an imaging device. It uses X-rays to create images of the internal structures of the body (heart, cardiovascular system, etc.) through computer reconstruction of transmission data.
- Specimen Use: This device does not examine specimens derived from the human body in vitro. It directly images the patient's body.
Therefore, based on the provided information, the Philips Brilliance CT in the Private Practice CV configuration is a Computed Tomography X-Ray System, which is a type of medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The "Brilliance CT, Private Practice CV configuration" is a Computed Tomography X-Ray System intended to produce cross-sectional images of the heart, cardiovascular, and peripheral vascular systems by computer reconstruction of x-ray transmission data taken at different angles and planes.
The Philips Brilliance CT in the Private Practice CV configuration is a Computed Tomography X-Ray System intended to produce images of the heart, Cardiovascular (including the carotids), and peripheral vascular systems (including PACS, aorta, iliac, and other distal vessels imaged by CT angiography and lower extremity veins) 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.
Contraindications for Use:
Philips Brilliance CT configurations that are defined as non-cardiac and non-vascular (including soft tissue and bone).
Product codes (comma separated list FDA assigned to the subject device)
90JAK
Device Description
The "Brilliance CT, Private Practice CV configuration" is a Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors, gantry, and multi-slice capability of up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the heart, cardiovascular, and peripheral vascular systems 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
Computed Tomography X-Ray
Anatomical Site
heart, cardiovascular (including the carotids), and peripheral vascular systems (including PACS, aorta, iliac, and other distal vessels imaged by CT angiography and lower extremity veins)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
0
K04 2293
SEP - 8 2004
Philips Medical Systems Inc. 510(k) Summary
"Brilliance CT, Private Practice CV configuration" CT Scanner
1. Submitter
Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, OH 44143 (440) 483-3000
Contact:
Robert L. Turocy Philips Medical Systems 595 Miner Road Cleveland, OH 44143 Telephone: 440 483 3528 440 483 2989 FAX:
Date of Summary: July 12,2004
2. Device Name and Classification
Device Name: "Brilliance CT, Private Practice CV configuration" CT Scanner
Classification Name: Computed Tomography X-Ray System
The FDA has classified the Computed Tomography X-Ray System as Class II in 21 CFR 892.1750 (Product Code 90JAK)
3. Device Description
The "Brilliance CT, Private Practice CV configuration" is a Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors, gantry, and multi-slice capability of up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the heart, cardiovascular, and peripheral vascular systems taken at different angles and planes. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.
4. Intended Use Of The Device
The "Brilliance CT, Private Practice CV configuration" is a Computed Tomography X-Ray System intended to produce cross-sectional images of the heart, cardiovascular, and peripheral vascular systems by computer reconstruction of x-ray transmission data taken at different angles and planes.
1
5. Comparison to Predicate Devices
The "Brilliance CT, Private Practice CV configuration" CT scanner has the same technological characteristics such as design, material, and energy source as the predicate devices identified. In the opinion of Philips Medical Systems Inc., the "Brilliance CT, Private Practice CV configuration" CT scanner is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely:
6. Safety and Effectiveness Considerations
The safety of the device is assured by adherence to GMP practices and to International Standards. 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 were adhered to, and test results demonstrate that the option specifications and functional requirements were met.
Material and Construction, as well as Electrical and Mechanical safety is assured by adherence to IEC 60601-1 standards and associated collateral and particular standards.
Radiation safety is assured by compliance with 21 CFR, Subchapter J performance standards.
Laser safety is assured by compliance to IEC 60625 standards
7. Substantial Equivalency Statement
Based on the above considerations, it is Philips's opinion that the "Brilliance CT, Private Practice CV configuration" CT scanner is substantially equivalent in safety and effectiveness to the predicate devices, Brilliance CT 40 Slice configuration, K033326 and Mx8000 IDT, K012009.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Philips Medical Systems (Cleveland) % Mr. Tamas Borsai Program Manager, Third Party Review Program TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K042293
Trade/Device Name: Brilliance CT, Private Practice CV Configuration Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system
Regulatory Class: II Product Code: 90 JAK Dated: August 17, 2004 Received: August 24, 2004
Dear Mr. Borsai:
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.
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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms icter will and in you to obgen finding of substantial equivalence of your device to a legally promative notification. "The Presults 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 It you desire specifice at ne of the following numbers, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Active of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on Jour respensional Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K042293 510(k) Number (if known):
Page 1 of 1
"Brilliance CT, Private Practice CV configuration" Device Name:
Indications for Use:
The Philips Brilliance CT in the Private Practice CV configuration is a Computed Tomography X-Ray System intended to produce images of the heart, Forlography A Ray DJ Steenslammary veins) and peripheral vascular systems Carolovasounar (morading Pals, aorta, iliac, and other distal vessels imaged by (Including the caronics) by computer reconstruction of x-ray transmission allers with on on on planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Contraindications for Use:
Configuredions for CTS. f he I millps Drimance that are defined as non-cardiac and non-vascular (including soft tissue and bone).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042293