FACTS MONOBLOCK

K981267 · Dynarad Corp. · IZX · May 6, 1998 · Radiology

Device Facts

• Record ID: K981267
• Device Name: FACTS MONOBLOCK
• Applicant: Dynarad Corp.
• Product Code: IZX · Radiology
• Decision Date: May 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1610
• Device Class: Class 2

Indications for Use

General Purpose Fluoroscope Applications

Device Story

The Monoblock is a diagnostic X-ray tube housing assembly used in fluoroscopic imaging systems. It functions as a protective housing for the X-ray tube, managing high-voltage components and radiation shielding. It is intended for use in clinical settings by trained radiological technologists or physicians. The device integrates into larger diagnostic imaging systems to facilitate the generation of X-ray beams for patient examination. It does not perform image processing or analysis; it serves as a hardware component for radiation delivery.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Diagnostic X-ray tube housing assembly. Class II device (21 CFR 892.1610). Procode: IZX, ITY, IZO. Functions as a protective enclosure for X-ray generation components.

Indications for Use

Indicated for general purpose fluoroscopic imaging applications.

Regulatory Classification

Identification

A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.

Special Controls

*Classification.* Class II (special controls). The 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 6 1998

Raymond Manez Director, Q.A./ Regulatory Affairs DynaRad Corporation 19 Jefryn Blvd. West Deer Park, NY 11729

Re:

K981267 Facts Monoblock Diagnostic X-Ray Tube Housing Assembly Dated: April 2, 1998 Received: April 7, 1998 Regulatory class: II 21 CFR 892.1610/Procode: 90 IZX/90 ITY/90 IZO

Dear Mr. Manez:

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 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 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 equivalier determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 (301) 594-639. 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/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. 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): K981267

Device Name: Monoblock

Indications For Use:

General Purpose Fluoroscope Applications

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Virgil A. Severson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K981267

(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109)

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