SHIMADZU CEILING TUBE SUPPORT CH-30GH

K990715 · Shimadzu Corp. · KPR · Apr 16, 1999 · Radiology

Device Facts

• Record ID: K990715
• Device Name: SHIMADZU CEILING TUBE SUPPORT CH-30GH
• Applicant: Shimadzu Corp.
• Product Code: KPR · Radiology
• Decision Date: Apr 16, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The CH-30GH is used to take the radiography of patients in standing position or . lying position. The intended for use of the CH-30GH are also the same as of the predicate device of the CH-30GX (K934005) .

Device Story

The CH-30GH is a ceiling-mounted tube support system used in clinical radiology settings. It functions as a mechanical support structure to position an X-ray tube for patient imaging. Operated by trained radiology personnel, the device facilitates the alignment of the X-ray source relative to the patient, who may be positioned standing or lying down. By providing stable and adjustable support, it enables the acquisition of diagnostic radiographic images. The device does not perform automated analysis or image processing; it serves as a mechanical positioning aid for standard radiographic equipment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Ceiling-mounted mechanical tube support system. Designed for manual positioning of X-ray tubes. No electronic sensing, software, or energy-based processing components. Mechanical assembly for radiographic imaging support.

Indications for Use

Indicated for patients requiring radiographic imaging in either standing or lying positions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CH-30GX (K934005)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 16 1999

Shimadzu Corp. c/o Shimadzu Medical Systems Michael Fishback 20101 South Vermont Avenue Torrance, CA 90502

Re:

K990715 Shimadzu Ceiling Tube Support, CH-30GH Dated: March 1, 1999 Received: March 4, 1999 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR

Dear Mr. Fishback:

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). 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,

DAFFTER, L.G. Sclatt, 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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## Page 17 Notification Submission, CH-30GH 210(K) INTENDED USE SECTION XII:

Page1 of1

510(K) Number(if known) : ____________________________________________________________________________________________________________________________________________________

CH-30GH Device Name:

Intended Use :

The CH-30GH is used to take the radiography of patients in standing position or . lying position.

The intended for use of the CH-30GH are also the same as of the predicate device of the CH-30GX (K934005) .

(Please Do Not WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED )

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Dmd X. R. DAS

(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological D S10(k) Number