(16 days)
Not Found
No
The document describes standard digital image processing but does not mention AI, ML, or related concepts, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device is described as an imaging system used for fluoroscopic and spot-film imaging during diagnostic, surgical, and interventional procedures, which are investigative or preparatory steps, not direct treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is designed to provide imaging "during diagnostic, surgical and interventional procedures." This directly indicates a diagnostic purpose.
No
The device description clearly states it is comprised of two mobile units: a C-arm stand and a workstation, which are physical hardware components.
Based on the provided information, the OEC 9800 Plus Digital Mobile Imaging System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed for "fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures." This involves imaging within the patient's body, not analyzing samples outside the body.
- Device Description: The description details a C-arm stand with an x-ray tube and image intensifier, and a workstation for image display and processing. This is consistent with an imaging system used on a patient, not a device for analyzing biological samples.
- Input Imaging Modality: The input modalities are "Fluoroscopic, spot-film imaging," which are methods of generating images of the inside of a living body using X-rays.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
In summary, the OEC 9800 Plus is an in vivo imaging system used to visualize structures within the patient's body, which is distinct from an in vitro diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The OEC 9800 Plus Digital Mobile Imaging System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Examples of clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Product codes
OWB, JAA, OXO
Device Description
The OEC 9800 Plus is comprised of two mobile units: a C-arm stand and a workstation. The C-arm stand supports the high-voltage generator, x-ray controls, and a "C" shaped apparatus, which supports the x-ray tube on one end and an image intensifier on the other. The C-arm is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The mobile workstation, supports image display monitors, image processing and recording devices. Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DICOM 3.0. An auxiliary connection is provided for a Medrad angiographic injector system to facilitate synchronized acquisition of angiographic images during contrast media injection.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is used by health care professionals such as physicians, surgeons, cardiologists, radiologists and technologists in hospitals, outpatient clinics and other clinical environments.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GE OEC Medical Systems OEC 9800 Digital Mobile Imaging System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines, giving the logo a classic and recognizable appearance. The logo is simple, yet distinctive, representing the brand identity of General Electric.
APR 1 7 2002
K 021049
GE Medical Systems OEC
GE OEC Medical Systems, Inc. General Electric Company 384 Wright Brothers Drive, Salt Lake City, UT 84116-2862 http://www.gemedicalsystems.com
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Date:
March 25, 2002
Name of Submitter:
GE OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, UT 84116 801-328-9300
Corresponding Official:
Bill Gislason. Vice President, Quality Assurance, Regulatory, and Reliability
Device Proprietary Name:
OEC 9800 Plus Digital Mobile Imaging System
Classification Name:
System, X-ray, Fluoroscopic, Image-Intensified - or System, X-ray, Mobile
Common/Usual Names:
Mobile C-arm, Fluoroscopic Imaging System
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Substantial Equivalence:
The OEC 9800 Plus is substantially equivalent to the following device that is currently marketed:
- GE OEC Medical Systems OEC 9800 Digital Mobile Imaging System .
These devices are mobile C-arm type x-ray systems intended for fluoroscopic imaging. The systems each include a high-voltage x-ray generator and control. x-ray tube, image intensifier, video image displays, digital image processing and image storage capability, as well as conventional spot-film capability.
Device Description:
Indications For Use
The OEC 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
User Characteristics
The device is used by health care professionals such as physicians, surgeons, cardiologists, radiologists and technologists in hospitals, outpatient clinics and other clinical environments. It is expected that the device will be used on a daily basis. Users are trained by GE OEC applications speciallsts and/or qualified site personnel in the proper use of the device. The device labeling stipulates that only properly trained persons operate this equipment.
General Description
The OEC 9800 Plus is comprised of two mobile units: a C-arm stand and a workstation. The C-arm stand supports the high-voltage generator, x-ray controls, and a "C" shaped apparatus, which supports the x-ray tube on one end and an image intensifier on the other. The C-arm is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The mobile workstation, supports image display monitors, image processing and recording devices.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DICOM 3.0. An auxiliary connection is provided for a Medrad angiographic injector system to facilitate synchronized acquisition of angiographic images during contrast media injection.
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Standards:
The OEC 9800 Plus is designed in accordance with product safety requirements established in the following standards:
- · Federal Performance Standard for Diagnostic X-ray Systems (21 CFR 1020.30-32)
- · ANSI/NFPA 70 & 99 National Electrical Code and Standard for Health Care Facilities
- · UL 2601 Medical Electrical Equipment
- CSA-C22.2 No. 601.1-M90 . Medical Electrical Equipment
- · IEC 60601-1, Medical Electrical Equipment, General Requirements for Safety
- · IEC 60601-1-2, Medical Electrical Equipment, General Requirements for Safety, Electromagnetic Compatibility
- · IEC 60601-1-3, Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment
- · IEC 60601-2-7. Medical Electrical Equipment, Safety of HV/X-ray Generators
- · IEC 60601-2-32, Medical Electrical Equipment, Safety of Associated X-ray Equipment
- · 93/42/EEC Annex 1 Essential Requirements of the Medical Devices Directive
This concludes this 510(k) Summary.
Bill Dickson
Vice President, Quality Assurance, Regulatory, and Reliability Bill Gislaso GE OEC Medical Systems, Inc.
WAG/dh
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles in blue, layered on top of each other, creating a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Bill Gislason Vice President, Quality Assurance. Regulatory and Reliability GE OEC Medical Systems, Inc. 384 Wright Brothers Drive SALT LAKE CITY UT 84116-2862
MAY 22 2012
Re: K021049
Trade/Device Name: OEC 9800 Plus Digital Mobile Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB. JAA and OXO Dated: March 25, 2002 Received: April 1. 2002
Dear Mr. Gislason:
This letter corrects our substantially equivalent letter of November 14, 2011.
We have reviewed your 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
4
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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510(k) Nolification
GE OEC Medical Systems, Inc.
OEC 9800 Plus
Indications For Use Statement
GE OEC Medical Systems, Inc. Applicant:
510(k) No. (if known):
OEC 9800 Plus Digital Mobile Imaging System Device name:
The OEC 9800 Plus Digital Mobile Imaging System is designed to Indications for use: provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Examples of clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
(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)
OR
Over-The-Counter_**_
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number _**_ K021049