(30 days)
No
The document describes a standard fluoroscopy system with image processing capabilities, but there is no mention of AI or ML in the intended use, device description, or any of the performance study sections.
No
This device is an imaging system designed to provide fluoroscopic and spot-film images for diagnostic and procedural guidance, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures." The mention of "diagnostic" directly indicates its use for diagnosis.
No
The device description explicitly states it consists of a mobile C-arm and OEC Workstation, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is used to image the patient directly using X-rays.
- The intended use and device description clearly describe an imaging system for visualizing internal structures of the patient. It's used during procedures on the patient, not for analyzing samples from the patient.
The OEC Olympus Mobile Fluoroscopy System is a medical imaging device, specifically a fluoroscopy system.
N/A
Intended Use / Indications for Use
The OEC Olympus Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
Product codes
90 JAA, IZL
Device Description
The OEC Olympus Mobile Fluoroscopy System is an image intensified fluoroscopic system consisting of a mobile C-arm and OEC Workstation. The C-arm supports the high-voltage generator, x-ray tube, x-ray controls, and image intensifier. The C-arm is designed to perform linear and rotational motions that allow the user to position the xray imaging components at various angles and distances with respect to the patient. The OEC workstation is a mobile platform that supports image display monitors, image processing and recording devices.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Koti937
AUG 1 8 2004
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: | July 14, 2004 |
|---|---|
| Name of Submitter: | GE OEC Medical Systems, Inc. |
| 384 Wright Brothers Drive | |
| Salt Lake City, UT 84116 | |
| 801-536-4668 | |
| Corresponding Official: | Jeff Wagner |
| Manager, Regulatory Affairs | |
| Device Proprietary Name: | OEC Olympus Mobile Fluoroscopy System |
| Classification Name: | Image Intensified Fluoroscopic X-ray System with Image |
| Processing System | |
| Common/Usual Names: | Fluoroscopic Imaging System |
| Substantial Equivalence: | The OEC Olympus Mobile Fluoroscopy System is substantially |
| equivalent to the: | |
| • OEC 9800 Plus Digital Mobile Imaging System (K021049) | |
| marketed by GE OEC Medical Systems, Inc. | |
| • OEC 9800 E/CV+ Digital Mobile Systems (K024012) | |
| marketed by GE OEC Medical Systems, Inc. |
1
Indications for Use
The OEC Olympus Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
General Description
The OEC Olympus Mobile Fluoroscopy System is an image intensified fluoroscopic system consisting of a mobile C-arm and OEC Workstation. The C-arm supports the high-voltage generator, x-ray tube, x-ray controls, and image intensifier. The C-arm is designed to perform linear and rotational motions that allow the user to position the xray imaging components at various angles and distances with respect to the patient. The OEC workstation is a mobile platform that supports image display monitors, image processing and recording devices.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCR's. 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 angiographic injector system to facilitate synchronization of angiographic images during contrast media injections.
2
Product Standards
The OEC Olympus Mobile Fluoroscopy System is designed in accordance with product safety and performance requirements established in the following standards:
| 21 CFR 1020.30-32 | Federal Performance Standard for Diagnostic X-ray Systems |
|---|---|
| ANSI/NFPA 70 & 99 | National Electrical Code and Standard for Health Care Facilities |
| UL 60601 | 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, Electromagnetic Compatibility |
| IEC 60601-1-3 | Medical Electrical Equipment, Radiation Protection in Diagnostic |
| X-ray | |
| IEC 60601-1-4 | Medical Electrical Equipment, Programmable Electrical Medical |
| Systems | |
| IEC 60601-2-7 | Medical Electrical Equipment, HV/X-ray Generators |
| IEC 60601-2-28 | Medical Electrical Equipment, X-ray Tube and Source Assemblies |
| 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.
GE OEC MEDICAL SYSTEMS, INC.
Jeff Wagner
Jeff Wagner Manager, Regulatory Affairs
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2004
Mr. Jeff Wagner Manager, Regulatory Affairs GE OEC Medical Systems, Inc. General Electric Company 384 Wright Brothers Drive SALT LAKE CITY UT 84116-2862 Re: K041932 Trade/Device Name: OEC Olymups Mobile Fluoroscopy System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: 90 JAA and IZL Dated: July 14, 2004 Received: July 19, 2004
Dear Mr. Wagner:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave roviously four over wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner or provision to may 20, 2017 accordance with the provisions of the Federal Food, Drug, devices that have ooon require approval of a premarket approval application (PMA). and Cosmolo Flor (110.) that the device, subject to the general controls provisions of the Act. The r ou may, iter erovisions 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 (Special Controls) or class III (PMA), it If your device is elabilion (von a controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 that I Dri has hastou a severations administered by other Federal agencies. You must comply of any I back is requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product quality by sentrol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ought marketing of substantial equivalence of your device to a legally premarket notheation. The PDA miding of easification 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), please If you desire specific advice to your of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Adultionally, for questions on the problems as a so, please note the regulation entitled, "Misbranding Other of Othphanos at ( notification" (21CFR Part 807.97) you may obtain. Other gencral by receive to premarked notificancer (er the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 14andfulerer of , meethant address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Boyden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use Statement
| Applicant: | GE OEC Medical Systems, Inc. |
|---|---|
| 510(k) No. (if known): | |
| Device name: | OEC Olympus Mobile Fluoroscopy System |
| Indications for use: | The OEC Olympus Mobile Fluoroscopy System is designed to provide |
| fluoroscopic and spot-film images of the patient during diagnostic, | |
| surgical and interventional procedures. Examples of clinical application | |
| may include cholangiography, endoscopy, urologic, orthopedic, | |
| neurologic, vascular, cardiac, critical-care and emergency room | |
| procedures. The system may be used for other imaging applications at | |
| the physicians discretion. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | --- |
OR
Over-The-Counter _______
(Optional Format 1-2-96)
Concurrence of CDRH Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K041932 |