(52 days)
Not Found
No
The document mentions "digital image processing" but does not mention AI, ML, or any related terms, nor does it describe any characteristics typically associated with AI/ML-powered devices (training/test sets, performance metrics like AUC, etc.).
No
The device is described as an x-ray imaging system intended for diagnostic purposes, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the systems are intended for "radiographic/fluoroscopic diagnostic" applications.
No
The device description clearly states it is comprised of hardware components such as an x-ray source/image receptor positioning device, C-Arm configuration, patient table, image intensifier/CCD camera, and motorized motions. While it mentions digital image processing, this is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging." This describes an imaging system used on a patient to visualize internal structures, not a device used to examine specimens outside the body (which is the definition of an IVD).
- Device Description: The description details an x-ray system with a C-Arm, patient table, and image intensifier/CCD camera. This is consistent with an in-vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the Omega Medical Imaging, Inc. CS-Series system is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Omega Medical Imaging, Inc. CS-Series systems are intended for use in radiographic/fluoroscopic cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
Product codes
JAA, IZI
Device Description
The Omega Medical Imaging, Inc. CS-Series systems are comprised of an x-ray source/image receptor positioning device in a permanently floor mounted C-Arm configuration with options of either an elevating only or elevating/tilt patient table. The system may also be configure with a ceiling suspended "C" for bi-plane operation. The positioning of the source/receptor is achieved by motorized motions controlled by the operator. The imaging is achieved by way of an image intensifier/CCD camera with digital image processing.
Mentions image processing
The imaging is achieved by way of an image intensifier/CCD camera with digital image processing.
Mentions AI, DNN, or ML
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Input Imaging Modality
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
OMEGA MEDICAL IMAGING, INC.
510(k) SUMMARY
MAY 1 8 2007
| Company Name: | Omega Medical Imaging, Inc |
|---|---|
| Address: | 675 Hickman Circle |
| Sanford, FL 32771 | |
| Telephone No: | 407-323-9400 |
| Registration No.: | 1052701 |
| Contact person: | James A. Princehorn |
| Date Prepared: | 1 February 2007 |
| Device (trade) name: | CS-Series radiographic/fluoroscopy system |
| Classification Name: | Angiographic X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 892.1650 and 892.1600 |
| Device Class: | Class II |
| Device Code: | JAA, IZI |
| Common/usual name: | System, X-Ray, Fluoroscopic, Image-Intensified |
Predicate device(s):
- Siemens AXIOM ARTIS U Angiography System (K040675) .
- Philips Integris H5000 Angiography System (K984545) .
- Omega Medical Imaging e-VIEW Fluoroscopy System (K062647). .
Device description:
- The Omega Medical Imaging, Inc. CS-Series systems are comprised of an x-ray source/image . receptor positioning device in a permanently floor mounted C-Arm configuration with options of either an elevating only or elevating/tilt patient table. The system may also be configure with a ceiling suspended "C" for bi-plane operation. The positioning of the source/receptor is achieved by motorized motions controlled by the operator. The imaging is achieved by way of an image intensifier/CCD camera with digital image processing.
Intended use:
- The Omega Medical Imaging, Inc. CS-Series systems are intended for use in . radiographic/fluoroscopic cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
1
Safety information:
- The Omega CS-Series systems will comply with the applicable requirements of 21 CFR . 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32.
- The Omega CS-Series systems will comply with the international safety standards IEC 60601-. 1, IEC 60101-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32 .
- The Omega CS-Series systems will comply with UL 60601-1 and CAN/USA C22.2 No.601.1-. M90
Software/Firmware
Omega Medical Imaging, Inc. manufactures the mechanical sub-systems for the CS-series systems. The control of these mechanical sub-systems is achieved without involvement of software or firmware. Omega Medical Imaging, Inc. obtains certified components from FDA registered suppliers that contain software/firmware. Omega Medical Imaging does not modify any of the software/firmware obtained by the suppliers. Omega Medical Imaging, Inc. conducts Vendor Audits of these suppliers to assure that these vendored components are suitable for this application.
Conclusion:
The Omega CS-Series systems do not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Omega considers the CS-Series systems to be substantially equivalent with the predicate devices.
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Image /page/2/Picture/0 description: The image shows a logo with three stylized, overlapping figures that resemble birds in flight or abstract human figures. The figures are depicted in black and are arranged diagonally, creating a sense of movement or progression. To the left of the figures, there is text arranged vertically along a curved path, but the text is too small to read.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. James A. Princehorn President Omega Medical Imaging, Inc. 675 Hickman Circle SANFORD FL 32771
MAY 1 8 2007
Re: K070834
Trade/Device Name: CS-Series Fluoroscopy System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: JAA and IZL Dated: March 22, 2007 Received: March 27, 2007
Dear Mr. Princehorn:
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.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "PA" in a stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the logo.
Protecting and Promoting Public Health
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Page 2 -
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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/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
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Omega Medical Imaging, Inc.
Omega Medical Imaging, Inc. CS-series Radiographic/Fluoroscopic Systems
Indications for Use:
The Omega Medical Imaging, Inc. CS-Series systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
Prescription Use ✓
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K070834