(63 days)
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No
The document describes a standard mobile digital C-arm system with image processing capabilities, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance study sections. The focus is on the hardware and basic digital image processing.
No
This device is described as providing imaging for diagnostic, surgical, and interventional procedures, which indicates its purpose is for imaging and diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures." This directly indicates its role in diagnostic processes.
No
The device description clearly states it is comprised of two mobile units, including a C-arm unit with hardware components like a high-voltage generator, x-ray components, and an image intensifier. This indicates it is a hardware-based medical device with integrated software for image processing and control.
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, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The Series 7600 Mobile Digital C-arm is an imaging device that uses X-rays to create images of the inside of a patient's body while the patient is present. This is an in vivo procedure (performed within the living body).
- Intended Use: The intended use clearly states it provides "fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures." This involves imaging the patient directly, not analyzing samples taken from the patient.
The description of the device, its components (C-arm, X-ray tube, image intensifier), and its use in clinical settings for imaging procedures all confirm it is an imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Series 7600 Mobile Digital C-arm 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.
Product codes
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Device Description
The Series 7600 system is comprised of two mobile units: the C-arm unit supports the high-voltage generator, x-ray components and x-ray controls; and the other unit, a mobile workstation, supports image display monitors, image processing and recording devices. The C-arm includes a "C" shaped arm that 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.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for U.S. domestic markets, CCIR format for international markets, and DICOM 3.0.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
Fluoroscopic
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
The device is used by health care professionals such as physicians, surgeons, cardiologists, radiologists and technologists. The device is used in hospitals, out-patient clinics and other clinical environments to provide fluoroscopic and spot-film imaging during diagnostic, surgical and interventional procedures. 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.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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Image /page/0/Picture/0 description: The image shows the logo for OEC Medical Systems, Inc. The logo consists of the letters "OEC" stacked on top of the words "OEC MEDICAL SYSTEMS, INC". The letters "OEC" are in a bold, sans-serif font, and the words "OEC MEDICAL SYSTEMS, INC" are in a smaller, serif font. The logo is black and white.
384 WRIGHT brothers drive
MAR 1 1 1997
SALT LAKE CITY. UTAH 84116
801-328-9300 FAX 801-328-4300 K970063
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:
December 31, 1996
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:
Series 7600 Mobile Digital C-arm
Classification Name:
System, X-ray, Fluoroscopic, Image-Intensified
Common/Usual Names:
Fluoroscopic Imaging System Mobile C-arm
1
Substantial Equivalence:
The Series 7600 Mobile Digital C-arm is substantially equivalent to the following systems which are currently marketed:
- OEC Medical Systems - Compact 7600
- Philips Medical Systems BV 25 Gold ●
- Siemens Medical Systems Siremobil Compact ●
All of these devices are mobile C-arm type diagnostic x-ray systems intended for fluoroscopic imaging. The systems all include a high-voltage x-ray generator, x-ray tube, image intensifier, video image displays, digital image processing and image storage capability.
Device Description:
Indications For Use
The Series 7600 Mobile Digital C-arm 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. The device is used in hospitals, out-patient clinics and other clinical environments to provide fluoroscopic and spot-film imaging during diagnostic, surgical and interventional procedures. 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 Series 7600 system is comprised of two mobile units: the C-arm unit supports the high-voltage generator, x-ray components and x-ray controls; and the other unit, a mobile workstation, supports image display monitors, image processing and recording devices. The C-arm includes a "C" shaped arm that 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.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for U.S. domestic markets, CCIR format for international markets, and DICOM 3.0.
2
Standards:
In addition to complying with the Federal Performance Standard for Diagnostic X-ray Systems (21 CFR §1020.30-32), the Series 7600 Mobile Digital C-arm is designed in accordance with product safety requirements established in the following standards:
UL 2601-1, 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
Fhis concludes this 510(k) Summary.
Ains
Ted L. Parrot, Vice President, Quality Assurance/Regulatory Affairs OEC Medical Systems, Inc.
TLP/jw