(71 days)
The 4R and 5 mobile x-ray unit with image intensifier system has been designed for diagnosis, suitable for x-ray and radioscopy, and radiography dedicated to:
- Traumatology .
- Paediatrics
- Interventional radiology
- Peace maker implantation
- Operating theater
- Intensive care .
- Respiratory system ●
- Skeleton .
This device does not foresee any interaction with medicine, while the possibility of an interface with some devices like VCR or THERMAL PRINTER is foreseen.
C-Quest 4R and 5 mobile x-ray unit with image intensifier system
The provided document is a 510(k) premarket notification letter from the FDA for a device called "C-Quest 4R and C-Quest 5." This document grants market clearance based on substantial equivalence to a predicate device.
Crucially, this document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study demonstrating the device meets acceptance criteria.
The 510(k) clearance process primarily evaluates substantial equivalence to existing legally marketed devices, focusing on indications for use and safety/effectiveness concerns addressed through general controls and potentially special controls for Class II devices. It does not typically require the submission of detailed performance studies against specific acceptance criteria in the same way a PMA (Premarket Approval) might.
Therefore, I cannot extract the requested information from the provided text. The document is essentially an FDA clearance letter, not a study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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ladd
Ms. Brenda S.D. Davis Quality and Regulations Manager Wuestec Medical, Inc. 5600 Commerce Boulevard East Mobile, AL 36619
SEP : : 1
Dear Ms. Davis:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K992103 Re: C-Quest 4R and C-Quest 5 Dated: June 15, 1999 Received: June 22, 1999 Regulatory Class: Il (two) Product Code: 90 IZL & 90 JAA 21 CFR 892.1720 & 892.1650
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 dass 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CART Daniel O. Schultz, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K992103
Device Name:
C-Quest 4R and 5
Indications For Use:
The 4R and 5 mobile x-ray unit with image intensifier system has been designed for diagnosis, suitable for x-ray The 4\ and o mobile x ray and radioscopy, and radiography dedicated to:
- Traumatology .
- Paediatrics
- Interventional radiology
- Peace maker implantation
- Operating theater
- Intensive care .
- Respiratory system ●
- Skeleton .
This device does not foresee any interaction with medicine, while the possibility of an interface with some devices like VCR or THERMAL PRINTER is foreseen.
David A. Segerson
(Division Sign-Off) (Children of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Submitted by: Brenda S. D. Davis Correspondent: partias . N. Signature
ﻨﺴ
Date: 8/2/99
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.