(15 days)
Not Found
No
The document describes a standard angiographic x-ray system and its components, with no mention of AI or ML capabilities in the intended use, device description, or specific sections for AI/ML mentions.
No
The device is an x-ray imaging system used for diagnosis and intervention guidance, not for direct therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures..." and the "Device Description" also mentions it's for "cardiovascular and vascular diagnostic and interventional procedures."
No
The device description clearly states it is an "angiographic x-ray system with a solid state x-ray imaging device" and describes hardware components like a "flat dynamic x-ray detector" and a "G-arm frontal stand." This indicates it is a hardware system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Philips Integris Allura Flat Detector system is an x-ray imaging system. It uses x-rays to create images of the cardiovascular and vascular systems within the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "cardiovascular and vascular x-ray imaging applications," including diagnostic and interventional procedures. This involves imaging the internal structures directly, not analyzing biological samples.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Philips Integris Allura Flat Detector release 1.2 system is intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.
Product codes (comma separated list FDA assigned to the subject device)
90 IZI, 90 MBQ
Device Description
The Philips Integris Allura Flat Detector release 1.2 system is an angjographic x-ray system with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. The monoplane system can be configured either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cesium iodide scintilator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques. X-ray images are detected with a flat dynamic x-ray detector and are recorded on digital storage medium. The system offers the functionality to review and analyze the images. Digital images with corresponding patient and examination data may be archived on digital storage media, video or laser hardcopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Cardiovascular and vascular
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
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. 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
MAY 1 3 2003
Image /page/0/Picture/1 description: The image shows a logo for Philips. The logo is in the shape of a shield with the word "PHILIPS" at the top. Inside the shield is a globe with two wavy lines across the middle. There are also two towers on the globe.
16031333
Philips Medical Systems
510(k) SUMMARY
The following information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Company Name: | Philips Medical Systems North America Company |
|---|---|
| Address: | 22100 Bothell Everett Highway |
| P.O. Box 3003 | |
| Bothell, WA 98041-3003, USA | |
| Registration No.: | 1217116 |
| Contact Person: | Lynn Harmer |
| Telephone No.: | (425) 487-7312 |
| Date Prepared: | April 16, 2003 |
| Device (Trade) Name: | Philips Integris Allura Flat Detector release 1.2 system |
| Classification Name: | Angiographic x-ray system, Class II, 90 IZI |
| Solid x-ray Imager, Class II, 90 MBQ |
Predicate Device:
The Philips Integris Allura Flat Detector release 1.2 system is substantially equivalent to the Philips Integris Allura Flat Detector release 1.0 system manufactured by Philips Medical Systems and GE Innova 4100 system. The Philips Integris Allura Flat Detector release 1.0 system received a 510(k) substantially equivalent determination in K022899 on November 22, 2002. The solid state x-ray Imaging device is the same product in both of the Integris Allura systems.
Device description:
The Philips Integris Allura Flat Detector release 1.2 system is an angjographic x-ray system with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. The monoplane system can be configured either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cesium iodide scintilator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques.
1
K031 333
510(k) Summary Philips Integris Allura Flat Detector System, release 1.2 Page 2 of 2
X-ray images are detected with a flat dynamic x-ray detector and are recorded on digital storage medium. The system offers the functionality to review and analyze the images.
Digital images with corresponding patient and examination data may be archived on digital storage media, video or laser hardcopy.
Indications for Use:
The Philips Integris Allura Flat Detector release 1.2 system is intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.
General Safety and Effectiveness:
The device and the labeling will comply with the applicable requirements of 21CFR, Subchapter J - Radiological Health, parts 1020.30, 32 and 1040.10 The device will comply with applicable requirements of the Underwriters Laboratories Standard for Safety UL 2601-1 and be classified by Underwriters Laboratories. The Philips Integris Allura Flat Detector release 1.2 system will also comply with the ACR/NEMA DICOM digital imaging communication standard.
Conclusion:
The Philips Integris Allura Flat Detector release 1.2 system is substantially equivalent in safety and effectiveness to the predicate devices identified.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2003
Philips Medical Systems North America Company % Mr. Morten S. Christensen Senior Project Engineer Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050
Re: K031333
Trade/Device Name: Philips Integris Allura Flat Detector release 1.2 Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulation Class: II Product Code: 90 IZI Dated: April 23, 2003 Received: April 28, 2003
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 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 v 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 (OS) 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
Page 2
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 the letter:
| 8xx. 1xxx | (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 Office 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 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K0313333
Indications for Use statement
510(k) Number (if known):
Philips Integris Allura Flat Detector release 1.2 Device Name:
Indications for Use:
The Philips Integris Allura Flat Detector release 1.2 system is intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031333
Prescription Use ./
(Per 21 CFR 801.109)
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OR
Over-The-Counter Use ......