(63 days)
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Not Found
No
The summary describes a mechanical patient support table for x-ray systems and does not mention any AI or ML components or functions.
No
The device is described as a patient support table for diagnostic x-ray systems, facilitating patient positioning during radiological procedures. It does not perform any therapeutic function.
No
Explanation: The "Intended Use / Indications for Use" states that the table is for "support patients during general purpose radiological procedures." The "Device Description" also describes it as a "patient support" table with an integrated bucky and tower, which are components of an X-ray system, but the table itself does not perform diagnostics.
No
The device description clearly outlines a physical patient support table with mechanical components (angulation, tabletop motion, bucky, tower), indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states this device is a patient support table used in a diagnostic x-ray system. Its function is to position and support the patient during imaging procedures.
- No Sample Analysis: The device does not interact with or analyze any samples taken from the patient. It is purely a physical support and positioning device.
Therefore, based on the provided information, this device falls under the category of a general medical device used in imaging, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
90 IXR
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1980 Radiologic table.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circle. There are three decorative swirls around the circle, one at the top and two at the bottom.
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 - (414) 544-3894 FAX - (414) 544-3863
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.
1
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
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 (301) 594-4613. Additionally, for question 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/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
2
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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__________________________________________________________________________________________________________________________________________________________