SYMPHONY 360 REMOTE CONTROL TABLE

K981227 · Acoma Medical Imaging, Inc. · JAA · Jun 30, 1998 · Radiology

Device Facts

• Record ID: K981227
• Device Name: SYMPHONY 360 REMOTE CONTROL TABLE
• Applicant: Acoma Medical Imaging, Inc.
• Product Code: JAA · Radiology
• Decision Date: Jun 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Symphony 9090 is intended to be used for routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, arthrography, myelography, interventional, emergency, and trauma radiology).

Device Story

Symphony 9090 is a remote-controlled radiographic table system. It supports patient positioning for various diagnostic imaging procedures, including gastrointestinal, chest, bone, arthrography, myelography, interventional, emergency, and trauma radiology. Operated by clinicians in a radiology setting, the device facilitates routine radiography and follow-up imaging. It functions as a mechanical platform for patient support and positioning during X-ray acquisition. By enabling precise patient orientation, the device assists clinicians in obtaining diagnostic images, thereby supporting clinical decision-making for patient diagnosis and treatment monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Remote-controlled radiographic table for patient positioning. System is designed for routine and follow-up radiography. No specific materials, software algorithms, or connectivity standards are detailed in the provided documentation.

Indications for Use

Indicated for patients requiring routine radiography and follow-up x-rays, including gastrointestinal, chest, bone, arthrography, myelography, interventional, emergency, and trauma radiology procedures.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 1998

Jim Lambrecht Official Correspondent Progråm Director Acoma Medical Imaging Inc. 150 Chaddick Drive Wheeling, Illinois 60090

Re:

K981227

Symphony 9090 Remote Control Table Dated: March 30, 1998 Received: April 3, 1998 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA

Dear Mr. Lambrecht:

We have reviewed your Section 510%) 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 II (Scecial Controls) or 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 (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 reculatory 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 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 predication 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/dsmaldsmamain.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{1}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Indications for use:

9090

The Symphony 200 is intended to be used for routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, arthrography, myelography, interventional, emergency, and trauma radiology).

David A. Bergman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)