(65 days)
The Quantum Medical Imaging, LLC Universal System is a stationary radiographic imaging system used for acquiring radiographic images of various anatomical regions of the human body.
The QV-800 Universal System is a walland floor-mounted column with an attached "swivel-arm". The QV-800 Universal System's "swivel-arm" design allows the x-ray tube and image receptor to remain in constant alignment as the arm is rotated and as the image receptor is anqulated. The QV-800 Universal System is designed for use in hospitals, imaging centers, and clinics.
The provided document is a 510(k) summary for the QV-800 Universal System, a stationary X-ray system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes for test/training sets, ground truth establishment, or expert involvement for AI/algorithmic performance evaluation.
The 510(k) summary focuses on the regulatory process of establishing substantial equivalence for a conventional medical device (an X-ray system) to legally marketed predicate devices, rather than on the performance evaluation of an AI-based or algorithmic device against specific acceptance criteria.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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NOV 1 3 2002
SECTION 2
SUMMARY AND CERTIFICATION
510(k) SUMMARY
Submitted by:
Scott Matovich Quantum Medical Imaging, LLC. 2905 Veterans Memorial Highway Ronkonkoma, NY 11779 USA
September 3, 2002
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Contact Person:
Mark Camirand Director of Q.A./Compliance Phone: (631) 567-5800, (631) 567-5074 (fax)
2. Device Name and Classification:
Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Device Code:
QV-800 Universal System Stationary X-ray System Radiology 21 CFR §892.1680 Class II 90KPR
3. Intended Use:
The Quantum Medical Imaging, LLC Universal System is a stationary radiographic imaging system used for acquiring radiographic images of various anatomical regions of the human body.
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4. Substantially Equivalent Devices:
Quantum Medical Imaging, LLC. believes the QV-800 Universal System is substantially equivalent to the following commercially distributed devices: Cares Built Flex-Rav THESEON (unknown 510(k) number) System and Pausch COSMOS-2 Universal X-Ray Unit (K870856).
5. Device Description:
The QV-800 Universal System is a walland floor-mounted column with an attached "swivel-arm". The QV-800 Universal System's "swivel-arm" design allows the x-ray tube and image receptor to remain in constant alignment as the arm is rotated and as the image receptor is anqulated. The QV-800 Universal System is designed for use in hospitals, imaging centers, and clinics.
6. Summary of Technological Characteristics as Compared with Predicate Device(s):
The QV-800 Universal System has verv similar technoloqical characteristics as the predicate devices. The QV-800 Universal System fulfills its design requirements by providing the operator with the ability to perform safe and effective radiographic examinations.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott Matovich President Quantum Medical Imaging, LLC 2905 Veterans Memorial Highway RONKONKOMA NY 11779
Re: K023008
Trade/Device Name: Universal System QV-800 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 KPR Dated: September 3, 2002 Received: September 9, 2002
Dear Mr. Matovich:
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); 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.
Image /page/2/Picture/11 description: The image shows a partial view of a logo or emblem. On the left side, a portion of text is visible, reading 'DEPARTMENT OF HEALTH' arranged in a curved manner. To the right, there are three stylized, curved lines that appear to be a design element of the logo. The overall image is in black and white.
Trade/D
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This letter will allow you to begin marketing your device as described in your 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:
| 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" (21 CFR Part 807.97). 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
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Page 1 of 1
510(k) Number (if known): KO23008
QV-800 Universal System Device Name: ______________
Indications for Use:
The QV-800 Universal System is a stationary radiographic imaging system used for acquiring radiographic images of various anatomical regions of the human body.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Chint A. bepm
(Optional Format 3-10-98)
(Division Sign-Off) Division of Don - 1 : 510(K) Number ___
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.