(97 days)
Not Found
No
The document describes a standard digital radiographic X-ray system and does not mention any AI or ML capabilities. The focus is on hardware components, image acquisition, and basic image processing (DICOM networking, image pasting).
No
The device is described as an imaging system intended to generate digital radiographic images for diagnostic purposes, not for treating any medical condition.
No.
The device is described as an X-ray system that generates digital radiographic images. Its intended use is to create images of body parts for routine radiography exams, not to interpret or diagnose from those images.
No
The device description explicitly lists multiple hardware components (WallStand, elevating table, overhead Tube support, X-ray tube, collimator, system controller, X-ray generator, and wireless or tethered digital detector) and the performance studies mention hardware changes and testing.
Based on the provided information, the Optima XR646 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for generating radiographic images of various body parts in patients. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically involving analysis of biological samples).
- Device Description: The description details an X-ray system with components like an X-ray tube, detector, and supports. This is consistent with medical imaging equipment used on patients, not laboratory equipment for analyzing samples.
- Input Imaging Modality: The input is Digital Radiographic X-Ray, which is a method of imaging the inside of the body.
- Anatomical Site: The specified anatomical sites are parts of the human body.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. The Optima XR646 does not perform this type of analysis.
N/A
Intended Use / Indications for Use
The Optima XR646 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and is intended for use in all routine radiography exams.
The device is not intended for mammographic applications.
Product codes (comma separated list FDA assigned to the subject device)
KPR, MQB
Device Description
The Optima XR646 remains a radiographic X-ray system capable of generating radiographic images of human anatomy.
The Optima XR646 is designed to handle radiographic applications using GE's flat-panel wireless digital detector. The digital detector is comprised of amorphous silicon and cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing and storage.
The Optima XR646 Digital Radiographic Imaging system consists of a WallStand, elevating table, overhead Tube support, X-ray tube, collimator, system controller, X-ray generator, and wireless or tethered digital detector. Various configurations such as Table only, WallStand only, or OTS only are available to meet customer radiographic requirements.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital Radiographic
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
all ages
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
The Optima XR646 is based on the software and Hardware platform of the predicate device. It was designed and is manufactured under GE's quality system that meets the Quality System Regulations of 21 CFR 820 and ISO 13485. Optima XR646 is certified to comply with the X-ray requirements of 21 CFR Subchapter J - Radiological Health, as well as safety requirements of IEC 60601-1 and associated collateral and particular standards. The Optima XR646 and its applications comply with voluntary standards. The following quality assurance measures were applied to the development of the system:
■ Risk Analysis
■ Requirements Reviews
■ Design Reviews
■ Testing on unit level (Module verification)
■ Integration testing (System verification)
■ Performance testing (Verification)
Safety testing (Verification) Simulated use testing (Validation)
The changes that precipitated this 510(k) submission were the reduction in auto positioning axes of the Overhead Tube Support that resulted in a change in the sequence of acquisitions for the Image Pasting feature.
The Image Pasting feature change does not affect the functional equivalence of the product today. These differences do not raise new issues of safety and effectiveness. The Overhead Tube Support hardware change and the Overhead Tube Support movement control software change for Image Pasting function were verified and validated through bench testing. All the design inputs requirements were successfully tested for Optima XR646 with Image Pasting and meet the design specifications and user requirements. This Verification and Validation bench testing demonstrated that no adverse effects have been introduced by the changes. The control mechanism, operating principle, energy type and Intended use have not changed. The indication for use is slightly modified to reflect the removal of the VolumeRad feature from this version of the product also due to the reduction of auto positioning axes on the Overhead Tube Support.
Summary of Clinical Tests: The subject of this premarket submission, Optima XR646, did not require clinical studies to support substantial equivalence. All changes were verified and validated during bench testing and did not reveal any new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in a dark color, creating a silhouette effect. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2016
GE Hualun Medical Systems Co., Ltd. Kennv Ma Regulatory Affairs Manager - X ray No.1, Yong Chang North Road Economic & Technology Development Zone Beijing, 100176 CHINA
Re: K143270
Trade/Device Name: Optima XR646 Regulation Number: 21 CFR 892.1680 Regulation Name: Station X-ray System Regulatory Class: Class II Product Code: KPR, MQB Dated (February 3, 2015): Received (February 5, 2015):
Dear Kenny Ma:
This letter corrects our substantially equivalent letter of February 3, 2015.
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
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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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Astest Oclo
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) K143270
Device Name Optima XR646
Indications for Use (Describe)
The Optima XR646 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and is intended for use in all routine radiography exams.
The device is not intended for mammographic applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has a white border and a few white swirls around the edge, giving it a dynamic and recognizable appearance.
510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | October 29, 2014 |
|---|---|
| Submitter: | GE Healthcare, (GE HUALUN MEDICAL SYSTEMS CO. Ltd) |
| No.1 Yong Chang North Road, Beijing Economic | |
| Technological Development Zone BEIJING 100176 CHINA | |
| Primary Contact Person: | Kenny Ma |
| Regulatory Affairs Manager | |
| GE Healthcare, (GE HUALUN MEDICAL SYSTEMS CO. Ltd) | |
| Office: +8610 59347159 | |
| eFax: +8610 67882574 | |
| Email: Kenny.Ma@ge.com | |
| Secondary Contact | |
| Person: | Christopher Paulik |
| RA Leader - Product | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| +1 262 548 2010 | |
| Email: Christopher.A.Paulik@ge.com | |
| Device Trade Name: | Optima XR646 |
| Common/Usual Name: | Digital Radiographic X-Ray System |
| Classification Names: | |
| Product Code: | Stationary X-Ray System (21CFR § 892.1680), solid state x- |
| ray imager (21CFR § 892.1680) | |
| KPR, MQB | |
| Predicate Device(s): | Stationary X-Ray System, MODEL: Discovery XR656 |
| (K132261) and Revolution XR/d with Image Pasting | |
| (K050704) | |
| Device Description: | The Optima XR646 remains a radiographic X-ray system |
| capable of generating radiographic images of human | |
| anatomy. | |
| The Optima XR646 is designed to handle radiographic | |
| applications using GE's flat-panel wireless digital detector. | |
| The digital detector is comprised of amorphous silicon and | |
| cesium iodide scintillator. The resulting digital image can | |
| be sent through a DICOM network for applications such as | |
| printing, viewing and storage. | |
| The Optima XR646 Digital Radiographic Imaging system | |
| consists of a WallStand, elevating table, overhead Tube | |
| support, X-ray tube, collimator, system controller, X-ray | |
| generator, and wireless or tethered digital detector. | |
| Various configurations such as Table only, WallStand only, | |
| or OTS only are available to meet customer radiographic | |
| requirements. | |
| Intended Use: | General Purpose Digital Radiographic Imaging System |
| Indication for Use: | The Optima XR646 is intended to generate digital |
| radiographic images of the skull, spinal column, chest, | |
| abdomen, extremities, and other body parts in patients of | |
| all ages. Applications can be performed with the patient | |
| sitting, standing, or lying in the prone or supine position | |
| and is intended for use in all routine radiography exams. | |
| The device is not intended for mammographic | |
| applications. | |
| Technology: | The Optima XR646 employs the same fundamental |
| scientific technology as its predicate device. | |
| Determination of | |
| Substantial Equivalence: | Summary of Non-Clinical Tests: |
| The Optima XR646 is based on the software and Hardware | |
| platform of the predicate device. It was designed and is | |
| manufactured under GE's quality system that meets the | |
| Quality System Regulations of 21 CFR 820 and ISO 13485. | |
| Optima XR646 is certified to comply with the X-ray | |
| requirements of 21 CFR Subchapter J - Radiological | |
| Health, as well as safety requirements of IEC 60601-1 and | |
| associated collateral and particular standards. | |
| The Optima XR646 and its applications comply with | |
| voluntary standards. The following quality assurance | |
| measures were applied to the development of the system: | |
| ■ Risk Analysis | |
| ■ Requirements Reviews | |
| ■ Design Reviews | |
| ■ Testing on unit level (Module verification) | |
| ■ Integration testing (System verification) | |
| ■ Performance testing (Verification) | |
| Safety testing (Verification) Simulated use testing (Validation) | |
| Minor obsolescence and feature changes have occurred in the evolution of the device for which a 510(k) was not required based on evaluation using the FDA "Deciding When to Submit a 510(k) for a change to an Existing Device". These include changes in operator display and the reduction of option in overhead rails. The changes that precipitated this 510(k) submission were the reduction in auto positioning axes of the Overhead Tube Support that resulted in a change in the sequence of acquisitions for the Image Pasting feature. | |
| The Image Pasting feature change does not affect the functional equivalence of the product today. These differences do not raise new issues of safety and effectiveness. The Overhead Tube Support hardware change and the Overhead Tube Support movement control software change for Image Pasting function were verified and validated through bench testing. All the design inputs requirements were successfully tested for Optima XR646 with Image Pasting and meet the design specifications and user requirements. This Verification and Validation bench testing demonstrated that no adverse effects have been introduced by the changes. The control mechanism, operating principle, energy type and Intended use have not changed. The indication for use is slightly modified to reflect the removal of the VolumeRad feature from this version of the product also due to the reduction of auto positioning axes on the Overhead Tube Support. | |
| Based on the successful verification, validation, and bench testing and the above comparison, GE Healthcare believes that the Optima XR646 is as safe and effective and performs in a substantially equivalent manner to the predicate device. | |
| Summary of Clinical Tests: The subject of this premarket submission, Optima XR646, did not require clinical studies to support substantial equivalence. All changes were verified and validated during bench testing and did not reveal any new questions of safety and effectiveness. | |
| Conclusion: | GE Healthcare considers the Optima XR646 to be as safe |
| and effective, and performance is substantially equivalent | |
| to the predicate device. |
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Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The letters are white, and the circle has a white outline, creating a contrast that makes the logo stand out.
510(k) Premarket Notification Submission
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510(k) Premarket Notification Submission
Image /page/5/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are three white, flame-like shapes surrounding the circle, giving the impression of movement or energy.
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Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are three wave-like shapes emanating from the circle, positioned at the top, bottom, and right side of the circle. The logo is simple and recognizable, representing the multinational conglomerate corporation.