XRT 600 R/F, WRF 0600

K992603 · Wuestec Medical, Inc. · JAA · Oct 25, 1999 · Radiology

Device Facts

• Record ID: K992603
• Device Name: XRT 600 R/F, WRF 0600
• Applicant: Wuestec Medical, Inc.
• Product Code: JAA · Radiology
• Decision Date: Oct 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The XRT 600 R/F and his component part is a device to visualize anatomical rne ANT 600 701 and nie compon of x-radiation into a vişual image through electronic amplification and to position a radiographic film cassette to obtain radiographs during fluoroscopy.

Device Story

XRT 600 R/F is a radiographic/fluoroscopic (R/F) imaging system. Device converts x-radiation into visual images using electronic amplification; includes mechanism to position radiographic film cassettes for image capture during fluoroscopy. Used in clinical settings by trained medical personnel to visualize internal anatomy for diagnostic purposes. Output is a visual image displayed for clinician review to support diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiographic/fluoroscopic imaging system; utilizes electronic image amplification; includes mechanical cassette positioning components. Class II device (21 CFR 892.1650).

Indications for Use

Indicated for visualization of anatomical structures via electronic amplification of x-radiation and positioning of radiographic film cassettes for fluoroscopic 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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Public Health Service

OCT 2 5 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Brenda S. D. Davis Quality and Regulations Manager WUESTEC 5600 Commerce Blvd. E. Mobile, AL 36619

K992603 XRT 600 R/F Dated: August 2, 1999 Received: August 3, 1999 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA

Dear Ms. Davis:

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.

Re:

If your device is classified (see above) into either class 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,

CAPT Daniel S. 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): `

Device Name:

Indications For Use:

The XRT 600 R/F and his component part is a device to visualize anatomical rne ANT 600 701 and nie compon of x-radiation into a vişual image through electronic amplification and to position a radiographic film cassette to obtain radiographs during fluoroscopy.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David W. Seyum
(Division Sign-Off) A

Division of Reproductive, Abdominal, ENT, and Radiological Devices 1492603 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)