C-QUEST

K992103 · Wuestec Medical, Inc. · OWB · Sep 1, 1999 · Radiology

Device Facts

• Record ID: K992103
• Device Name: C-QUEST
• Applicant: Wuestec Medical, Inc.
• Product Code: OWB · Radiology
• Decision Date: Sep 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

Mobile x-ray unit with image intensifier; used for diagnostic radiography and radioscopy. Operates in clinical settings including operating theaters and intensive care units; utilized by physicians and clinical staff. Inputs consist of x-ray radiation; system transforms inputs into visual images for diagnostic review. Supports peripheral connectivity via VCR or thermal printer interfaces. Assists clinicians in surgical guidance, trauma assessment, and patient monitoring; facilitates real-time imaging for procedures like pacemaker implantation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Mobile x-ray unit with image intensifier; includes interfaces for external recording/printing devices (VCR, thermal printer).

Indications for Use

Indicated for diagnostic x-ray, radioscopy, and radiography in traumatology, pediatrics, interventional radiology, pacemaker implantation, operating theater, intensive care, respiratory system, and skeletal imaging.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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Date: 8/2/99