LEGACY/LEGACY-D TABLE

K973039 · GE Medical Systems · IXR · Oct 16, 1997 · Radiology

Device Facts

• Record ID: K973039
• Device Name: LEGACY/LEGACY-D TABLE
• Applicant: GE Medical Systems
• Product Code: IXR · Radiology
• Decision Date: Oct 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1980
• Device Class: Class 2

Intended Use

This table is intended for use in a diagnostic x-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions.

Device Story

Legacy/Legacy-D Radiologic Table; patient support system for diagnostic x-ray procedures. Provides angulation to +/- 90 degrees; longitudinal and lateral tabletop motion. Includes integrated table bucky and spot film/fluoroscopic tower. Used in clinical radiology settings; operated by radiologic technologists or physicians. Supports patient positioning in horizontal, vertical, and trendelenburg orientations. Facilitates imaging by stabilizing patient during x-ray exposure; enables precise alignment of patient relative to imaging equipment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Radiologic patient support table; provides +/- 90 degree angulation; longitudinal and lateral tabletop motion. Includes integrated table bucky and spot film/fluoroscopic tower. Mechanical device; no software or electronic sensing/actuation described.

Indications for Use

Indicated for patients requiring support during general purpose radiological procedures in horizontal, vertical, and trendelenburg positions.

Regulatory Classification

Identification

A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.

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 § 892.9.

Submission Summary (Full Text)

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GE Medical Systems k973039

OCT 16 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

August 13, 1997

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)

IDENTIFICATION OF THE SUBMITTER:

Larry A. Kroger Phone - [phone] FAX - [phone]

Legacy/Legacy-D Radiologic Table IDENTIFICATION OF THE PRODUCT:

General Electric Co. Manufactured by: Medical Systems Division 3000 North Grandview Blvd. Waukesha, WI 53188

#### MARKETED DEVICE:

Legacy/Legacy-D Radiologic Table is substantially equivalent to currently marketed radiologic tables that comply with the same or equivalent standards and have the same intended uses.

#### DEVICE DESCRIPTION:

The Legacy/Legacy-D table is a patient support providing angulation to +/- 90 degrees and tabletop motion in the longitudinal and lateral directions. It includes an integrated table bucky and a spot film/fluoroscopic tower. The new bucky has the same function as the older version.

#### INDICATIONS FOR USE:

This table is intended for use in a diagnostic x-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions.

### CONCLUSIONS:

In the opinion of GE Medical Systems the Legacy/Legacy-D is as safe, and performs as well as other diagnostic x-ray tables of similar design having the same intended uses. The design of the Legacy/Legacy-D raises no new questions of safety or effectiveness.

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OCT 1 6 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Larry A. Kroger, Ph.D. Regulatory Affairs Program Manager GE Medical Systems, Inc. P.O. Box 414 Milwaukee. WI 53201

Re: K973039

Legacy/Legacy-D Table (Diagnostic X-Ray Table) Dated: August 13, 1997 Received: August 14, 1997 Regulatory class: II 21 CFR 892.1980/Procode: 90 IXR

Dear Dr. Kroger:

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, 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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 [phone]. Additionally, for question 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/dsmamain.html".

Sincerely yours,

h.7.liau Yu

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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1973039 510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

This table is intended for use in a diagnostic x-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions.

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

David le. Seymore

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973039

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________