(73 days)
Not Found
No
The summary describes a standard digital radiographic system with components like a detector, x-ray tube, and generator. There is no mention of AI, ML, or advanced image processing beyond basic digital image handling for viewing and storage. The focus is on replacing film/screen systems and achieving substantial equivalence to a predicate device based on hardware and intended use.
No.
The device is used to generate radiographic images for diagnostic purposes, not to treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" states, "It is Intended to replace radiographic film/screen systems in all general purpose diagnostic procedures." This explicitly indicates the device's diagnostic purpose.
No
The device description explicitly lists multiple hardware components including an elevating radiographic table, digital detector, x-ray tube, x-ray tube hanger, collimator, system controller, generator, and a vertical bucky stand. This indicates it is a hardware-based medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Revolution TX/ Digital Radiographic Table System is described as generating radiographic images of human anatomy using x-rays. It's a medical imaging device that works by passing radiation through the body and capturing the resulting image.
- Intended Use: The intended use is to "generate radiographic images of human anatomy" and "replace radiographic film/screen systems in all general purpose diagnostic procedures." This clearly describes an imaging function, not the analysis of biological specimens.
The description focuses on the hardware components (detector, x-ray tube, table, etc.) and the process of creating digital images from x-ray exposure, which is characteristic of a diagnostic imaging system, not an IVD.
N/A
Intended Use / Indications for Use
The Revolution TX/i Digital Radiographic Table System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film / screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Product codes
KPR, MOB
Device Description
The Revolution TX/i Digital Radiographic Table System is designed to perform radiographic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing and storage. The Revolution TX/i Digital Radiographic Table System consists of a an elevating radiographic table with integrated digital detector, x-ray tube, x-ray tube hanger, collimator, system controller, and generator. A separate, conventional SG100 vertical bucky stand is provided for chest or other general purpose radiographic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic x-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The device has the same detector and acquisition system as the predicate device, and the same intended uses. It will be evaluated for conformance with UL and IEC safety standards. We consider the device to be substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
GE Medical Systems
AUG 30 1999
f
General Electric Company PO Box 414, Milwaukee, WI 53201
K99 2066
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Pat 807.87(h).
| Identification of Submitter: | Larry A. Kroger, Ph.D.
Senior Regulatory Programs Manager
GE Medical Systems
Tel. (414) 544-3894
Summary prepared: June 15, 1999 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of Product: | Revolution TX/i Digital Radiographic Table System |
| Classification Name: | Stationary X-ray System |
| Manufacturer: | GE Medical Systems
3000 N. Grandview Blvd.
Waukesha, WI 53118 |
| Marketed Devices: | Digital detector (part of Digital Radiographic Imaging
System, renamed Revolution XQ/i system) (K982196);
SCX (Advantx) radiographic system (K862120);
Ultranet-SA Collimator (K894142); Maxiray 100
Radiographic Tube (Pre-amendment); SCPU Generator
(K940277) and SG100 vertical bucky stand (Pre-
amendment). |
| Device Description: | The Revolution TX/i Digital Radiographic Table System
is designed to perform radiographic x-ray examinations.
The detector is comprised of amorphous silicon with a
cesium iodide scintillator. The resulting digital image
can be sent through a DICOM network for applications
such as printing, viewing and storage. The Revolution
TX/i Digital Radiographic Table System consists of a an
elevating radiographic table with integrated digital
detector, x-ray tube, x-ray tube hanger, collimator,
system controller, and generator. A separate,
conventional SG100 vertical bucky stand is provided for
chest or other general purpose radiographic
procedures. |
| Indications for Use: | The Revolution TX/i Digital Radiographic Table System
is indicated for use in generating radiographic images
of human anatomy. It is intended to replace |
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radiographic film / screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
- Comparison with Predicate: The Revolution TX/i Digital Radiographic Table System is substantially equivalent to the Revolution XQ/i system, originally cleared as Digital Radiographic Imaging System in 510(k) K982196. The table used in the Digital Radiographic Table System is substantially equivalent to the Compax 40E table cleared in 510(k) K884930.
Summary of Studies: The device has the same detector and acquisition system as the predicate device, and the same intended uses. It will be evaluated for conformance with UL and IEC safety standards. We consider the device to be substantially equivalent to the predicate device.
GE considers the Revolution TX/i Digital Radiographic Conclusions: Table System to be equivalent with the predicate device. The TX/i Digital Radiographic Table System provides radiographic images that result in equivalent or better diagnostic capabilities than film / screen images. The potential hazards, e.g., wrong measurements and misdiagnosis, are controlled by a risk management plan including:
- · A Hazard Analysis
- · A Software Development and Validation Process
- · Certification to applicable UL and IEC safety standards
- · External evaluations
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 20 2013
Larry A. Kroger. Ph.D. Senior Regulatory Programs Manager General Electric Company PO Box 414 MILWAUKEE WI 53201
Re: K992066
Trade/Device Name: Revolution TX/I Digital Radiographic Table System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: June 17, 1999 Received: June 18, 1999
Dear Dr. Kroger:
This letter corrects our substantially equivalent letter of August 30, 1999.
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809): medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INTENDED USE
510(k) Number (if known): K992066
Device Name: Revolution TX/i Digital Radiographic Table System
Indications for Use
The Revolution TX/ Digital Radiographic Table System is indicated for use in generating radiographic images of human anatomy. It is Intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
(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)
ﮯ۔
OR Over-The-Counter Use_
David G. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number