(90 days)
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No
The document describes a standard mobile C-arm imaging system with digital image processing, but there is no mention of AI, ML, or related concepts.
No
The device is an imaging system designed for diagnostic procedures, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures." The word "diagnostic" directly indicates its use for diagnosis.
No
The device description clearly outlines hardware components such as a C-arm stand, high-voltage generator, x-ray tube, image intensifier, and a mobile workstation with monitors and processing devices. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The IMDIS is an imaging system that uses X-rays to visualize the internal structures of a patient in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes imaging procedures performed directly on the patient.
- Device Description: The description details components for generating and capturing X-ray images of the patient.
Therefore, the IMDIS falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The IMDIS is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, 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
90 JAA, 90 IZL
Device Description
The IMDIS 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 an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which 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 iniection.
Mentions image processing
digital image processing
Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
User Characteristics: The device is used by health care professionals such as physicians, surgeons, cardiologists, radiologists and technologists in hospitals, out-patient clinics and other clinical environments. It is expected that the device will be used on a daily basis. Users are trained by OEC applications specialists and and/or qualified site personnel in the proper use of the device. The device labeling stipulates that only properly trained persons operate this equipment.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
OEC Medical Systems SERIES 9600® Mobile Digital Imaging System, Philips Medical Systems BV 300 Series Mobile C-arm System
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/0 description: The image shows a logo for OEC Medical Systems, Inc. The logo consists of the letters "OEC" in a bold, sans-serif font, with three horizontal lines replacing the horizontal bar of the "E". Below the letters, the words "OEC MEDICAL SYSTEMS, INC." are printed in a smaller, sans-serif font.
381 WRICHU BROMERS DRIVE
SALI LARE CHY. ប់ ប្រព័ន្ធព្រៃច
801-328-9300 FAX 801 328 4000
FEB 1 7 1998
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:
November 14, 1997
Name of Submitter:
OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, UT 84116 801-328-9300
Corresponding Official:
Ted L. Parrot, Vice President, Quality/Regulatory Affairs.
Device Proprietary Name:
Interventional Mobile Digital Imaging System (herein called IMDIS)
Classification Name:
System, X-ray, Fluoroscopic, Image-Intensified - or System, X-ray, Mobile
Common/Usual Names:
Mobile C-arm, Fluoroscopic Imaging System
1
Substantial Equivalence:
The IMD/S is substantially equivalent to the following devices which are currently marketed:
- OEC Medical Systems SERIES 9600® Mobile Digital Imaging System .
- Philips Medical Systems BV 300 Series Mobile C-arm System .
These devices are mobile C-arm type x-ray systems intended for fluoroscopic imaging. The systems all 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 IMDIS is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, 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, out-patient clinics and other clinical environments. It is expected that the device will be used on a daily basis. Users are trained by OEC applications specialists 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 IMDIS 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 an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which 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 iniection.
2
Standards:
The IMDIS 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 601-1. Medical Electrical Equipment, General Requirements for Safety
- · IEC 601-1-2. Medical Electrical Equipment, General Requirements for Safety, Electromagnetic Compatibility
- · IEC 601-1-3, Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment
- · IEC 601-2-7, Medical Electrical Equipment, Safety of HV/X-ray Generators
- . IEC 601-2-32, 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.
Hamot
Ted L. Parrot, Vice President, Quality Assurance/Regulatory Affairs OEC Medical Systems, Inc.
TLP/jw
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of a stylized eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 1998
Ted L. Parrot Vice President, Quality Assurance/ Regulatory Affairs and Official Correspondent OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, Utah 84116
Re: K974355 Interventional Mobile Digital Imaging System Dated: November 14, 1997 Received: November 19, 1997 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA 21 CFR 892.1720/Procode: 90 IZL
Dear Mr. Parrott:
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 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 (OS) 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 yitro 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 vours.
William 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
4
510(k) Notification
Indications For Use Statement
| Applicant: | OEC Medical Systems, Inc. |
|---|---|
| 510(k) No. (if known): | K974355 |
| Device name: | Interventional Mobile Digital Imaging System (IMDIS) |
| Indications for use: | The IMDIS is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, 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)
C. Lejser
(Division Sign-Off)