(241 days)
No
The document explicitly states that the image processing is achieved with a "conventional computer based image processing system" and does not mention AI, ML, or related terms.
No
The device is described as an X-ray imaging system used for diagnostic purposes, not for treating or curing diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are "intended for use in Radiographic/fluroscopic applications including cardiac, vascular, general radiographic/fluroscopic diagnostic, and Interventional x-ray imaging." The term "diagnostic" directly indicates its use for diagnosis.
No
The device description clearly outlines hardware components such as flat-panel detectors, a floor-mounted c-arm, a patient table, and a ceiling-suspended C-arm. While it mentions image processing software, the device is fundamentally a physical x-ray imaging system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "Radiographic/fluroscopic applications including cardiac, vascular, general radiographic/fluroscopic 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 in vitro (outside the body).
- Device Description: The description details an x-ray imaging system with flat-panel detectors, C-arms, and a patient table. This is consistent with medical imaging equipment used for diagnostic and interventional procedures on living subjects.
- 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.
Therefore, the Omega Medical Imaging, LLC CS-series-FP (SSXI) Systems are medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The Omega Medical Imaging, LLC CS-series-FP (SSXI) Systems are intended for use in Radiographic/fluroscopic applications including cardiac, vascular, general radiographic/fluroscopic diagnostic, and Interventional x-ray imaging.
Product codes
OWB, JAA
Device Description
The Omega Medical Imaging, LLC, CS-series-FP systems currently incorporate a 19.8cm x 19.8cm or 29.8cm x 29.8cm solid-state flat-panel detector (FPD). This 510(k) submission adds a slightly larger 21.7cm x 21.7cm and 30.3cm x 30.3cm solid-state CMOS 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 patient table. The dual plane systems incorporate a ceiling suspended C-arm into the system. The MX CFP 3131 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 (separate from the Flat Panel Detector) which includes image processing, viewing functions, local storage, and DICOM compatibility. The Image Processor does not have the capability to connect to the internet as there is no browser.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-ray, Radiographic 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
SE was determined on Bench performance testing. Included in this report is detailed data comparing performance with the existing Omega Medical Imaging CS-series-FP system utilizing the 29.8cm x 29.8cm x 19.8cm x 19.8cm format FPD image acquisition systems. The tests that were performed utilized commercially available Test Object that include lowcontrast objects with varying absorbers simulating different patient sizes, spatial and temporal resolution test objects, and dynamic range test objects.
Key Metrics
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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February 9, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The Department of Health and Human Services logo is a stylized representation of an eagle. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Omega Medical Imaging, LLC % Mr. John Newman Manager of Regulatory and Quality 675 Hickman Circle SANFORD FL 32771
Re: K171755
Trade/Device Name: CS-series-FP with MX CFP 3131 or MX CFP 2222 Option radiographic/fluoroscopy system Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: January 4, 2018 Received: January 10, 2018
Dear Mr. Newman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171755
Device Name
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic / Fluoroscopy System
Indications for Use (Describe)
The Omega Medical Imaging, LLC CS-series-FP (SSXI) Systems are intended for use in Radiographic/fluroscopic applications including cardiac, vascular, general radiographic/fluroscopic diagnostic, and Interventional x-ray imaging.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Omega Medical Imaging. The logo consists of a blue circular symbol on the left, resembling the Greek letter omega. To the right of the symbol, the words "OMEGA MEDICAL" are written in a gray sans-serif font, with the word "IMAGING" below it in a smaller font size and separated by horizontal lines.
Special 510(k) SUMMARY
| Company Name: | Omega Medical Imaging, LLC |
|---|---|
| Address: | 675 Hickman Circle, Sanford, Florida 32771 |
| Telephone No: | 407-323-9400 |
| Registration No: | 1052701 |
| Contact person: | Brian J. Fleming |
| Date Prepared: | 05/26/2017 |
| Device (trade) name: | CS-series-FP with MX CFP 3131 or MX CFP 2222 Option |
| radiographic/fluoroscopy system | |
| Common/usual name: | Fluoroscopic/Radiographic X-ray system |
| Classification Name: | Solid State X-ray Imager, Class II, 90 MQB |
| Classification Panel: | Radiology |
| CFR section: | 892.1650 |
| Device Class: | Class II |
| Device Code: | 90 OWB / JAA |
Predicate Device(s):
- Omega Medical Imaging CS-series-FP (K121293)
Device description:
The Omega Medical Imaging, LLC, CS-series-FP systems currently incorporate a 19.8cm x 19.8cm or 29.8cm x 29.8cm solid-state flat-panel detector (FPD). This 510(k) submission adds a slightly larger 21.7cm x 21.7cm and 30.3cm x 30.3cm solid-state CMOS 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 patient table. The dual plane systems incorporate a ceiling suspended C-arm into the system. The MX CFP 3131 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 (separate from the Flat Panel Detector) which includes image processing, viewing functions, local storage, and DICOM compatibility. The Image Processor does not have the capability to connect to the internet as there is no browser.
Subject Device Flat Panel Detectors MX CFP 2222 / 3131 are to be used only with the Omega CSseries-FP Fluoroscopic Systems
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Indications for use:
- The Omega Medical Imaging, LLC CS-series-FP with Optional MX CFP 3131 and MX CFP 2222 are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
- The intended use of the modified device, as described in the labeling, has not changed as a result of the modification for this filling.
Comparison with Predicate Devices:
- · The Omega Medical Imaging MX CFP 2222 and 3131 option the CS-series-FP system utilizes the same technology as the above-mentioned predicate device. The input scintillator is Cesium lodide coupled to a CMOS-light sensitive imaging component. The image processing is achieved with conventional computer based image processing system that is separate from the Flat Panel Detector. The MX CFP 2222 and 3131 Flat Panel Detectors are manufactured by the same company as the Image Processor. It is the opinion of Omega Medical Imaging that the CS-series-FP with the MX CFP 2222 and MX CFP 3131 option is equivalent to the existing Omega Medical Imaging cleared CS-series-FP system.
Substantial Equivalence:
- · SE was determined on Bench performance testing. Included in this report is detailed data comparing performance with the existing Omega Medical Imaging CS-series-FP system utilizing the 29.8cm x 29.8cm x 19.8cm x 19.8cm format FPD image acquisition systems. The tests that were performed utilized commercially available Test Object that include lowcontrast objects with varying absorbers simulating different patient sizes, spatial and temporal resolution test objects, and dynamic range test objects.
- Guidance for this submission of 510(k) for (SSXID) Solid State X-ray Imaging Devices issued on: September 1, 2016 was used to establish substantial equivalence
Safety information:
- The Omega CS-series-FP with the MX CFP 2222 and MX CFP 3131 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 the MX CFP 2222 and MX CFP 3131 option systems comply with the international safety standards IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, and IEC 60601-2-43.
- · The Omega CS-series-FP with the MX CFP 2121 and MX CFP 3131 option systems comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90
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Conclusion:
The Omega CS-series-FP with the MX CFP 2222 and MX CFP 3131 options do not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Omega considers the Omega CS-series-FP with the MX CFP 2222 and MX CFP 3131 Flat panel detectors to be substantially equivalent with the predicate device.