(43 days)
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) .
Not Found
This document does not contain the information requested regarding acceptance criteria, study details, or performance metrics for a medical device.
The provided text is a 1999 FDA 510(k) clearance letter for the Shimadzu Ceiling Tube Support, CH-30GH, and a separate "Intended Use Section" for the same device.
Here's what the document does contain:
- FDA Clearance: It states that the device (Shimadzu Ceiling Tube Support, CH-30GH) has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (CH-30GX, K934005).
- Regulatory Class: Class II (21 CFR 892.1680 / Procode: 90 KPR).
- Intended Use: "The CH-30GH is used to take the radiography of patients in standing position or lying position." It also states the intended use is the same as the predicate device CH-30GX.
- Date: April 16, 1999.
Missing Information:
All the detailed information requested in the prompt, such as acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, is not present in these documents. These types of details would typically be found in the premarket notification (510(k) submission) itself, specifically in performance testing or clinical data sections, which are not provided here.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal features an emblem of an eagle with outstretched wings, with three wavy lines extending from the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
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 (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,
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
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.