(44 days)
Not Found
No
The description mentions "digital image processing" but does not include any terms or descriptions indicative of AI or ML, such as "artificial intelligence," "machine learning," "deep learning," "neural network," or descriptions of training/test data sets.
No
The device is described as an imaging system used for diagnostic purposes, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section states that the systems are intended for "diagnostic" x-ray imaging.
No
The device description clearly outlines hardware components such as an x-ray source/image receptor positioning device, a C-Arm configuration, motorized motions, a patient table with various motorized movements, and an image intensifier/CCD camera. While it mentions image processing, the core of the device is hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging." This describes a medical imaging device used to visualize internal structures of the body using X-rays.
- Device Description: The description details an X-ray system with a C-Arm, patient table, and image intensifier/CCD camera. This is consistent with a medical imaging device, not a device used to examine specimens in vitro (outside the body).
- 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.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is used to directly image the human body.
N/A
Intended Use / Indications for Use
The Omega Medical Imaging, Inc. e-VIEW systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
Product codes (comma separated list FDA assigned to the subject device)
DWB, JAA
Device Description
The Omega Medical Imaging, Inc. e-VIEW systems are comprised of an x-ray source/image receptor positioning device in a permanently floor mounted C-Arm configuration. The positioning of the source/receptor is schieved by motorized motions controlled by the operator. The patient table can be configured with different motorized motions including elevating, Trendelenburg and vertical tilt, lateral and longitudinal table top travel, and lateral table top tilt. The imaging is achieved by way of an image intensifier/CCD camera with digitty in nage processing.
Mentions image processing
The imaging is achieved by way of an image intensifier/CCD camera with digitty in nage processing.
Mentions AI, DNN, or ML
Not Found
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): 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.
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.
Not Found
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.
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OMEGA MEDICAL IMAGING, INC.
510(k) SUMMARY
| Company Name: | Omega Medical Imaging, Inc | |||
|---|---|---|---|---|
| Address: | 675 Hickman Circle | |||
| Sanford, FL 32771 | OCT 20 2006 | |||
| Telephone No: | 407-323-9400 | |||
| Registration No.: | 1052701 | |||
| Contact person: | James A. Princehorn | |||
| Date Prepared: | 14 April 2006 | |||
| Device (trade) name: | e-VIEW 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: | DWB & JAA | |||
| 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 B200/C300 Fluoroscopy System (K902005). .
Device description:
- The Omega Medical Imaging, Inc. e-VIEW systems are comprised of an x-ray source/image � receptor positioning device in a permanently floor mounted C-Arm configuration. The positioning of the source/receptor is schieved by motorized motions controlled by the operator. The patient table can be configured with different motorized motions including elevating, Trendelenburg and vertical tilt, lateral and longitudinal table top travel, and lateral table top tilt. The imaging is achieved by way of an image intensifier/CCD camera with digitty in nage processing.
Intended use:
- . The Omega Medical Imaging, e-VIEW systems are Inc. intended for use in radiographic/fluoroscopic applications including cardiac. vascular. general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
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Safety information:
- The Omega e-VIEW systems will comply with the applicable requirements of 21 CFR 1020.30, . 21 CFR 1020.31, and 21 CFR 1020.32.
- The Omega e-VIEW 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 e-VIEW systems will comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90 .
Conclusion:
The Omega e-VIEW 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 e-VIEW systems to be substantially equivalent with the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
FEB 1 9 2013
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. James A. Princehorn President Omega Medical Imaging, Inc. 675 Hickman Circle SANFORD FL 32771
Re: K062647
Trade/Device Name: e-VIEW Fluoroscopy System Model CS-50 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: August 31, 2006 Received: August 6, 2006
Dear Mr. Princehorn:
This letter corrects our substantially equivalent letter of October 20, 2006.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number: K 062647
Device Name: e-VIEW Fluoroscopy System, Model CS-50
Indications For Use:
The Omega Medical Imaging, Inc. e-VIEW systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional xray imaging.
(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 Use
David A. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K062647
510(k) Number
Omegs Medical Imaging e-VIEW 510(k)
Section I