(132 days)
The MCA-601, C-Arm Mobile is used for providing fluoroscopic and radiographic images of patient anatomy, especially during special procedures in a hospital or medical clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images in real time without the need to develop individual films.
High frequency X-ray generator and Image intensifier systems are mounted on C-arm transport mobile base.
The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for a C-Arm Mobile Fluoroscopic System, indicating a name change for an existing device and its intended use. It largely comprises administrative details, such as company information, device classification, and a letter from the FDA confirming substantial equivalence to legally marketed predicate devices.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance from the provided text.
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MAR 2 7 2000
510 (k) SUMMARY OF 21 CFR 807.92 FOR MODEL MCA-601 C-ARM MOBILE FLUOROSCOPIC SYSTEMS, IMAGE INTENSIFIED
x 993896
1.0 Device Name :
Trade Name : C-Arm Mobile X-Ray Systems
2.0 Reason for Submittal:
Model Name Change
- 3.0 Submitting Establishment :
Medison Radiology Systems, Inc 151 South Pfingsten Road, Unit V Deerfield, Illinois 60015
Establishment Registration No. : 1424247
Corresponding Official : John W. Lee, President 847 - 291 - 0999 Manufacturer : MedisonAcoma Co., Ltd 22-8, 3-Chome Hongo, Bunkyo-ku Tokyo, Japan
-
4.0 Panel and Device Classification :
Panel: Fluoroscopic Systems, Image Intensified Classification: II -
5.0 Description:
High frequency X-ray generator and Image intensifier systems are mounted on C-arm transport mobile base. See Appendix "A" for the system configuration and labeling data. -
6.0 Intended Use :
Producing fluoroscopic and general radiographic images for patient treatment and diagnosis. Especially being used during special procedures.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2000
John W. Lee President Medison Radiology Systems, Inc. 151 South Pfingsten Road, Unit V Deerfield, IL 60015
Re:
K993896 MCA-601, C-Arm Mobile Dated: February 28, 2000 Received: March 1, 2000 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA 21 CFR 892.1720/Procode: 90 IZL
Dear Mr. Lee:
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 pror to May 26, 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, isting 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 equivalent determination assumes compliance with the Current Sood 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 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) 594-4591. Additionally, for questions and allections of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitiled, "Misbranding by reference to premarket notification" (21CFR 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/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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510 (k) Number ( If known) : K993896 Device Name : MCA-601, C-arm mobile
Indication of Use :
The MCA-601, C-Arm Mobile is used for providing fluoroscopic and radiographic images of patient anatomy, especially during special procedures in a hospital or medical clinics.
The fluoroscopic mode of operation is very useful to the attending physician to see the images in real time without the need to develop individual films.
( Please do not write below this line - continue on the another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801. 109)
OR
Over - The - Counter - Use
(Optional Format 1-2-9)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993896
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.