(87 days)
Not Found
No
The document explicitly states that image processing is achieved with "conventional computer based image processing systems" and there is no mention of AI, ML, or related terms.
No
This device is an X-ray imaging system intended for diagnostic imaging, not for treating any medical conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are intended for "radiographic/fluoroscopic diagnostic" and "interventional x-ray imaging".
No
The device description explicitly details hardware components, including a flat-panel detector, C-arm, and patient table, indicating it is a hardware-based system with integrated software for image processing.
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 application including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging." This describes an imaging system used for visualizing internal structures of the body, not for examining specimens in vitro (outside the body).
- Device Description: The description details an x-ray imaging system with a flat-panel detector, C-arms, and a patient table. This is consistent with an in-vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the device is an in-vivo medical imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Omega Medical Imaging, LLC. CS-series-FP with 3030+ Option systems are . intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
Product codes
90 MQB, 90 IZI
Device Description
The Omega Medical Imaging, LLC. CS-series-FP systems currently incorporate a 19.8cm x 19.8cm solid-state flat-panel detector (FPD) as an option. This 510(k) submission adds a larger format (29.8cm x 29.8cm) flat-panel detector as an additional option. The CS-series-FP fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted C-arm and a patient table. The dual plane systems incorporate a ceiling suspended C-arm into the system. The flat-panel image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The captured digital image is processed by the acquisition system which includes image processing, viewing functions, local storage, and DICOM compatibility.
Mentions image processing
Yes
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)
SE was determined on non-clinical performance testing. Included in this report is detailed data comparing performance with the existing Omega Medical Imaging CS-series-FP system utilizing the 19.8cm x 19.8cm format FPD image acquisition system. The tests that were performed utilized commercially available Test Objects that include low-contrast objects with varying absorbers simulating different patient sizes, spatial and temporal resolution test objects, and dynamic range test objects. Also included is the "Non-clinical Considerations" of the flat-panel detector.
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.
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Omega Medical Imaging, LLC
JUL 26 2012
510(k) SUMMARY
Company Name: Omega Medical Imaging, LLC
675 Hickman Circle Address: Sanford, FL 32771
407-323-9400 Telephone No:
Registration No .: 1052701
Contact person: Brian J. Fleming
Date Prepared: 20 April 2012
CS-series-FP with 3030+ Option radiographic/fluoroscopy Device (trade) name: svstem
Common/usual name: Image Intensified Fluoroscopic X-ray System
Classification Name: Solid State X-ray Imager, Class II, 90 MQB Angiographic X-ray System, Class II, 90 IZI
Classification Panel: Radiology
CFR Section: 892.1650 and 892.1600
Device Class: Class II
90 MQB, 90 IZI Device Code:
Predicate device(s):
Omega Medical Imaging CS-series-FP (K100102) .
Device description:
The Omega Medical Imaging, LLC. CS-series-FP systems currently incorporate a 19.8cm x 19.8cm solid-state flat-panel detector (FPD) as an option. This 510(k) submission adds a larger format (29.8cm x 29.8cm) flat-panel detector as an additional option. The CS-series-FP fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted C-arm and a patient table. The dual plane systems incorporate a ceiling suspended C-arm into the system. The flat-panel image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The captured digital image is processed by the acquisition system which includes image processing, viewing functions, local storage, and DICOM compatibility.
Materials: The solid-state x-ray imager (FPD) construction and materials comply with UL2601-1, IEC60601-1, CSA 22.2 No. 601.1-M90, and is CE Marked. The imager is classified by Underwriters Laboratories.
1
Omega Medical Imaging, LLC
Intended use:
- The Omega Medical Imaging, LLC. CS-series-FP with 3030+ Option systems are . intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
Comparison with Predicate Devices:
- The Omega Medical Imaging large format option to the CS-series-FP system utilizes . identical technology of the above mentioned predicate device. The input scintillator is Cesium lodide coupled to a Thin-Film-Transistor (TFT) panel. The image processing is achieved with conventional computer based image processing systems. It is the opinion of Omega Medical Imaging that the CS-series-FP with 3030+ Option utilizing the larger format FPD detector is essentially equivalent to the existing Omega Medical Imaging cleared CS-series-FP system utilizing the smaller format FPD.
Substantial Equivalence:
- SE was determined on non-clinical performance testing. Included in this report is detailed . data comparing performance with the existing Omega Medical Imaging CS-series-FP system utilizing the 19.8cm x 19.8cm format FPD image acquisition system. The tests that were performed utilized commercially available Test Objects that include low-contrast objects with varying absorbers simulating different patient sizes, spatial and temporal resolution test objects, and dynamic range test objects. Also included is the "Non-clinical Considerations" of the flat-panel detector.
It is the opinion of Omega Medical Imaging that the CS-series-FP with 3030+ Option with the larger format FPD (29.8cm x 29.8cm) is essentially equivalent to the cleared Omega Medical Imaging CS-series-FP (K100102) smaller format detector systems.
Safety information:
- The Omega CS-series-FP with 3030+ Option systems comply with the applicable ● requirements of 21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32.
- The Omega CS-series-FP with 3030+ Option systems 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, IEC 60601-2-32, and IEC 60601-2-43.
- The Omega CS-series-FP with 3030+ Option systems comply with UL 60601-1 and . CAN/USA C22.2 No.601.1-M90
Conclusion:
The Omeqa CS-series-FP with 3030+ Option systems with the larger format (29.9cm x 29.9cm) FPD 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-FP with 3030+ Option systems with this larger format flat-panel detector to be substantially equivalent with the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread. The eagle is facing to the right and has three lines emanating from its body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JUL 26 2012
Mr. Brian J. Fleming President & CEO Omega Medical Imaging, LLC 675 Hickman Circle SANFORD FL 32771
Re: - K121293
Trade/Device Name: CS-series-FP with 3030+ Option Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and OWB Dated: April 20, 2012 Received: May 1, 2012
Dear Mr. Fleming:
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 requirences as 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 nonication. The 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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Indications for Use
510(k) Number (if known):
CS-series-FP with 3030+ Option Device Name:
Indications for Use:
The Omega Medical Imaging, LLC CS-series-FP with 3030+ Option systems are intended for use in radiographic/fluoroscopic application including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
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