(31 days)
K003837/A
No
The document describes a standard fluoroscopic C-arm system with image processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an imaging system (C-arm) used to acquire fluoroscopic and spot-film images for diagnostic and procedural guidance, not for direct therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical, critical-care and emergency room procedures." The inclusion of "diagnostic" directly indicates its use in diagnosing conditions.
No
The device description explicitly states it is an "image intensified fluoroscopic mobile C-arm system" and lists hardware components like a C-arm, high-voltage generator, x-ray tube, image intensifier, and CRT monitors. While it mentions image processing, the core device is a hardware system.
No, 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 (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The OEC Everview 7500 is a mobile digital C-arm that uses X-rays to create images of the patient's body directly. It does not analyze samples taken from the patient.
- Intended Use: The intended use clearly states it provides "fluoroscopic and spot-film images of the patient during diagnostic, surgical, critical-care and emergency room procedures." This involves imaging the patient's internal structures in real-time or as still images.
Therefore, based on the provided information, the OEC Everview 7500 is an in vivo imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OEC Everview 7500 is a mobile digital C-arm designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical, critical-care and emergency room procedures. Examples of clinical application may include, but are not limited to cholangiography, endoscopy, urology, vascular, orthopedic, neurology and cardiac procedures. It is anticipated that this product will be used on a daily basis by such users, as prescribed by the physician. The system may be used for other imaging applications at the physician's discretion.
Product codes (comma separated list FDA assigned to the subject device)
JAA, IZL
Device Description
The OEC Everview 7500 is an image intensified fluoroscopic mobile C-arm system. It consists of a C-arm that supports a high-voltage generator, x-ray tube, x-ray controls, image intensifier, and CRT monitors. It is designed to perform linear and rotational inlage interior, and Urer to position the x-ray imaging components at various angles motions that allow the bect to the patient, and supports image processing and recording devices.
Interfaces are provided for optional peripheral devices such as thermal printer and interfaces are provided for spompatible with CCIR format for international markets.
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): 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.
OEC Compact 7700 Mobile C-Arm (K000221)
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.
Flexiview 8800 Digital Mobile Imaging System (K003837/A)
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).
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
510(k) Notification
Date:
K 051490
GE OEC Everview 7500
7 - 2005
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.
June 2, 2005
- GE OEC Medical Systems, Inc. Name of Submitter: 384 Wright Brothers Drive Salt Lake City, UT 84116 801-536-4517 (F) 801-328-4300 Susan Schmidt Corresponding Official: Engineer - Safety & Regulatory Device Proprietary Name: GE OEC Everview 7500 Image Intensified Fluoroscopic X-ray System with Image Classification Name: Processing System / Mobile C-arm. Fluoroscopic Imaging System or Mobile C-arm. Common/Usual Names: The OEC Everview Mobile Digital C-Arm is substantially equivalent Substantial Equivalence: to the: OEC Compact 7700 Mobile C-Arm (K000221) marketed by GE . OEC Medical Systems, Inc.
- Flexiview 8800 Digital Mobile Imaging System (K003837/A) . marketed by GE OEC Medical Systems, Inc.
1
Indications for Use
The OEC Everview 7500 is a mobile digital C-arm designed to provide fluoroscopic and The OEO L'on how Poooatient during diagnostic, surgical, critical-care and emergency spor-illin images of the patient calinical application may include, but are not limited to room procedures: Examplos urology, vascular, orthopedic, neurology and cardiac cholangiography, ondoodop), arelegy , at thegy , and ily basis by such users, procedures. It is antiopician. The system may be used for other imaging applications at the physician's discretion.
General Description
The OEC Everview 7500 is an image intensified fluoroscopic mobile C-arm system. It consists of a C-arm that supports a high-voltage generator, x-ray tube, x-ray controls, image intensifier, and CRT monitors. It is designed to perform linear and rotational inlage interior, and Urer to position the x-ray imaging components at various angles motions that allow the bect to the patient, and supports image processing and recording devices.
Interfaces are provided for optional peripheral devices such as thermal printer and interfaces are provided for spompatible with CCIR format for international markets.
2
Product Standards
The OEC Everview 7500 is designed in accordance with product safety and performance requirements established in the following standards:
| Document | Description |
|---|---|
| Title 21 CFR, Subchapter J, Parts 807, | |
| 1020.30 through 1020.32 | U.S. requirements for 510(k) submissions, U.S. Federal |
| Performance Standard for Diagnostic X-ray Systems, U.S. | |
| Canadian Food & Drug Act SOR/98-292 | |
| 7 May 2004 | Health Canada- Canadian Medical Device Regulation |
| ANSI/NFPA 70 and 99 | US National Electric Code/Electrical Equipment, Health Care |
| Facilities | |
| UL 60601-1: 2003: 1st Edition | Medical Electrical Equipment, Part 1: General Requirements |
| for Safety including any Collateral Std (601-1-x) and | |
| Particular Std (601-2-x), as adopted. | |
| CSA-C22.2 No. 601.1-M90 | Medical Electrical Equipment, Part 1: General Requirements for |
| Safety including any Collateral Std (601.1.x) and Particular Std | |
| (601.2.x), as adopted. | |
| EN 60601-1 | |
| (IEC 60601-1:1988 + A1 & A2) | Medical Electrical Equipment, Part 1: General Requirements |
| for Safety | |
| IEC 60601-1-1:2000: 2nd edition | Collateral Std: Safety of Medical Electrical Systems |
| IEC 60601-1-2:2001: 2nd edition | Collateral Std: Electromagnetic Compatibility |
| IEC 60601-1-3:1994: 1st edition | Collateral Std: Radiation Protection in Diagnostic X-ray |
| Equipment | |
| IEC 60601-1-4:2000: 1.1 edition (+A1) | Collateral Std: Safety of Programmable Medical Systems |
| IEC 60601-2-7:1998: 2nd edition | Particular Std: Safety of H.V. Diagnostic X-ray Generators |
| IEC 60601-2-28:1993: 1st edition | Particular Std: Safety of X-ray Tube and X-ray Source |
| Assemblies | |
| IEC 60601-2-32:1994: 1st edition | Particular Std: Safety of Associated Equipment of X-ray |
| Equipment | |
| 93/42/EEC, Annex I | |
| (Essential Requirements) | Council Directive Concerning Medical Devices (European |
| Union) |
This concludes this 510(k) Summary.
GE OEC MEDICAL SYSTEMS, INC.
Susan Schmidt
Susan Schmidt, Engineer- Safety & Regulatory
3
Image /page/3/Picture/1 description: The image contains a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three curved lines representing its wings or body. The emblem is black and appears to be a symbol associated with the Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 7 - 2005
Ms. Susan Schmidt Engineer - Safety & Regulatory GE OEC Medical Systems, Inc. 384 Wright Brothers Drive SALT LAKE CITY UT 84116
Re: K051490
Trade/Device Name: OEC Everview 7500 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: JAA & IZL Dated: June 2, 2005 Received: June 6, 2005
Dear Ms. Schmidt:
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 either class II (Special Controls) or 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 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 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 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 radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter natification. The FDA finding of substantial equivalence of your device to a legally premation in a classification for your device and thus, permits 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 n you don't special of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Allot, production other general information on your responsibilities under the Act from the 001:57). I Canall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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
GE OEC Medical Systems, Inc. Applicant:
Kos1490 510(k) No. (if known):
OEC Everview 7500 Device name:
The OEC Everview 7500 is a mobile digital C-arm designed to Indications for use: provide fluoroscopic and spot-film images of the patient during diagnostic, surgical, critical-care and emergency room procedures. Examples of clinical application may include, but are not limited to cholangiography, endoscopy, urology, vascular, orthopedic, neurology and cardiac procedures. It is anticipated that this product will be used on a daily basis by such users, as prescribed by the physician. 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 |
|---|---|---|
| ------------------------------------------ | ---- | ------------------ |
| (Division Sign-Off) | Division of Reproductive, Abdominal, and Radiological Devices |
|---|---|
| 510(k) Number | K051490 |
| (Optional Format 1-2-96) |
GE OEC Medical Systems
Company Confidential