(27 days)
Not Found
No
The document mentions "image processing software" and "improves the algorithm for previewing images and image processing" but does not explicitly state or imply the use of AI or ML. The description of the AutoGrid feature also describes a traditional image processing technique for scatter reduction, not an AI/ML approach.
No
The device is described as a diagnostic imaging system, designed to generate medical x-rays to assist in detecting disease or injury, rather than treating or curing them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the AMX Navigate is "designed to generate diagnostic radiographic images (medical x-rays)" and is indicated for "general-purpose diagnostic radiographic examinations and procedures." The text also specifies its use "to detect disease or injury."
No
The device description clearly states it is a "self-contained; battery operated mobile radiographic imaging system" and mentions hardware components like a collapsible column and exposure switches, indicating it is a physical device with integrated software, not software-only.
Based on the provided information, the AMX Navigate is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- AMX Navigate Function: The AMX Navigate is a mobile radiographic imaging system. It generates medical x-rays to create images of the internal structures of the body. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "general purpose diagnostic radiographic procedures" and "taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts." This involves imaging the patient directly, not analyzing samples from the patient.
Therefore, the AMX Navigate falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The AMX Navigate is intended to take exposures utilizing film, computed radiography (CR), or wireless detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
AMX Navigate is a self-contained; battery operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects). The AMX Navigate is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to a traditional RAD room.
The system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.
This device is not intended for mammographic applications.
The AMX Navigate incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.
Product codes
IZL, MQB
Device Description
The AMX Navigate is intended to take exposures, using a wired or remote exposure switch, utilizing film, computed radiography (CR), or cleared wireless radiographic detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
AMX Navigate is a self-contained; battery operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects).
The AMX Navigate system is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room.
The incorporation of an optional collapsible column allows for improved workflow by delivering a less obstructed view when driving the system and includes a motion assist to reduce user efforts when driving the column vertically.
The system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.
This device is not intended for mammographic applications.
Mentions image processing
The AMX Navigate incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.
The software on the AMX Navigate has been modified to support the optional collapsible column and improves the algorithm for previewing images and image processing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray radiography
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
adult and pediatric patients
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)
Summary of Non-Clinical Tests:
The following quality assurance measures were applied to the development of the AMX Navigate 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) New risks were identified for incorporating the optional collapsible column and associated software into the AMX Navigate. These risks were reviewed and mitigated with design controls and labeling. The mitigations were verified and validated as a part of the design verification and validation testing that has been executed with acceptable results.
Summary of Clinical Tests:
The subject of this premarket submission, AMX Navigate, did not require clinical studies to support substantial equivalence of incorporating an optional collapsible column.
Design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Optima XR240amx with RFID (K182234)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
April 28, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Medical Systems, LLC % Martha Kamrow, Ph.D. Senior Regulatory Affairs Leader 3000 N. Grandview Blvd. WAUKESHA WI 53188
Re: K210982
Trade/Device Name: AMX Navigate Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB Dated: March 31, 2021 Received: April 1, 2021
Dear Dr. Kamrow:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K210982
Device Name AMX Navigate
Indications for Use (Describe)
The AMX Navigate is intended to take exposures utilizing film, computed radiography (CR), or wireless detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
AMX Navigate is a self-contained; battery operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects). The AMX Navigate is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to a traditional RAD room.
The system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.
This device is not intended for mammographic applications.
The AMX Navigate incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.
| 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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3
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date
| Submitted: | March 31 2021 |
|---|---|
| Submitter: | GE Medical Systems, LLC |
| 3000 N. Grandview Blvd | |
| Waukesha, WI 53188, USA | |
| Primary Contact | |
| Person: | Martha Kamrow |
| Senior Regulatory Affairs Leader | |
| GE Healthcare | |
| 262-548-2673 | |
| Martha.Kamrow@ge.com | |
| Secondary | |
| Contact Person: | Diane Uriell |
| Regulatory Affairs Senior Director | |
| GE Healthcare | |
| 262-290-8218 | |
| Diane.Uriell@ge.com | |
| Device Trade | |
| Name: | AMX Navigate |
| Common/Usual | |
| Name: | Mobile X-ray system |
| Regulation, | |
| Classification, | |
| and Product | |
| Code: | Regulation Name: Mobile X-Ray System |
| Regulation: 21 CFR 892.1720 | |
| Classification: Class II | |
| Product Codes: IZL, MQB | |
| Predicate | |
| Device(s): | Optima XR240amx with RFID (K182234) |
| Regulation Name: Mobile X-Ray System | |
| Regulation: 21 CFR 892.1720 | |
| Classification: Class II | |
| Product Codes: IZL, MQB | |
| Device | |
| Description: | The AMX Navigate is intended to take exposures, using a wired or remote |
| exposure switch, utilizing film, computed radiography (CR), or cleared | |
| wireless radiographic detectors, which are intended to replace | |
| radiographic film screen systems in all general purpose diagnostic | |
| procedures, for digital radiography (DR). | |
| AMX Navigate is a self-contained; battery operated mobile radiographic | |
| imaging system designed to generate diagnostic radiographic images | |
| (medical x-rays) that may increase the ability to detect disease or injury | |
| early enough for a medical problem to be managed, treated, or cured. | |
| Medical x-rays are used in many types of examinations and procedures, | |
| some examples include x-ray radiography (to find orthopedic damage, | |
| tumors, pneumonias, foreign objects). | |
| The AMX Navigate system is indicated for use on adult and pediatric | |
| patients for general-purpose diagnostic radiographic examinations and | |
| procedures. Its mobility enables general-purpose radiographic procedures | |
| throughout the clinical environment, or as needed within the emergency, | |
| intensive care, premature birth ward, cardiac and operating departments, | |
| for patients that may not be able to be moved or in cases where it is | |
| unsafe or impractical to move them to a traditional RAD room. | |
| The incorporation of an optional collapsible column allows for improved | |
| workflow by delivering a less obstructed view when driving the system and | |
| includes a motion assist to reduce user efforts when driving the column | |
| vertically. | |
| The system is indicated for taking radiographic exposures of the skull, | |
| spinal column, chest, abdomen, extremities, and other body parts with the | |
| patient sitting, standing, or lying in the prone or supine position. | |
| This device is not intended for mammographic applications. | |
| Intended Use / | |
| Indications for | |
| Use: | The AMX Navigate is intended to take exposures utilizing film, computed |
| radiography (CR), or wireless detectors, which are intended to replace | |
| radiographic film screen systems in all general purpose diagnostic | |
| procedures, for digital radiography (DR). | |
| AMX Navigate is a self-contained; battery operated mobile radiographic | |
| imaging system designed to generate diagnostic radiographic images | |
| (medical x-rays) that may increase the ability to detect disease or injury | |
| early enough for a medical problem to be managed, treated, or cured. | |
| Medical x-rays are used in many types of examinations and procedures, | |
| some examples include x-ray radiography (to find orthopedic damage, | |
| tumors, pneumonias, foreign objects). | |
| The AMX Navigate is indicated for use on adult and pediatric patients for | |
| general-purpose diagnostic radiographic examinations and procedures. Its | |
| mobility enables general-purpose radiographic procedures throughout the | |
| clinical environment, or as needed within the emergency, intensive care, | |
| premature birth ward, cardiac and operating departments, for patients | |
| that may not be able to be moved or in cases where it is unsafe or | |
| impractical to move them to a traditional RAD room. | |
| The system is indicated for taking radiographic exposures of the skull, | |
| spinal column, chest, abdomen, extremities, and other body parts with the | |
| patient sitting, standing, or lying in the prone or supine position. | |
| This device is not intended for mammographic applications. | |
| The AMX Navigate incorporates AutoGrid, which is an optional image | |
| processing software installed as a part of the systems Helix image | |
| processing software. AutoGrid can be used in lieu of an anti-scatter grid to | |
| improve image contrast in general radiographic images by reducing the | |
| effects of scatter radiation. | |
| Technology: | The AMX Navigate employs the same fundamental scientific technology as |
| the predicate device. They are both battery operated mobile x-ray | |
| systems that capture exposures utilizing film, CR plates, or a wireless | |
| detector. The intended use is the same between the AMX Navigate and | |
| the predicate device. The AMX Navigate did not change the input power, | |
| battery subsystem, drive subsystem, x-ray generation, and exposure | |
| control from the predicate devices. The difference being introduced is a | |
| modification to the hardware and software to incorporate an optional | |
| collapsible column. The incorporation of an optional collapsible column | |
| allows for improved workflow by delivering a less obstructed view when | |
| driving the system and includes a motion assist to reduce user efforts when | |
| driving the column vertically. The hardware on the AMX Navigate has been | |
| modified to include the optional collapsible column and a horizontal arm | |
| assembly to provide a longer travel range for the tube/collimator. The | |
| software on the AMX Navigate has been modified to support the optional | |
| collapsible column and improves the algorithm for previewing images and | |
| image processing | |
| Determination | |
| of Substantial | |
| Equivalence: | Summary of Non-Clinical Tests: |
| The following quality assurance measures were applied to the | |
| development of the AMX Navigate 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) New risks were identified for incorporating the optional collapsible column and associated software into the AMX Navigate. These risks were reviewed and mitigated with design controls and labeling. The mitigations were verified and validated as a part of the design verification and validation testing that has been executed with acceptable results. | |
| Summary of Clinical Tests: | |
| The subject of this premarket submission, AMX Navigate, did not require clinical studies to support substantial equivalence of incorporating an optional collapsible column. | |
| Design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results. | |
| Conclusion: | The AMX Navigate incorporates an optional collapsible column allowing for improved workflow by delivering a less obstructed view when driving the system and includes a motion assist to reduce user efforts when driving the column vertically. This update to this system does not result in any new potential safety risks, it has the same technological characteristics, and perform as well as the devices currently on the market. |
| After analyzing design verification and validation testing on the bench it is the conclusion of GE Healthcare that the AMX Navigate to be as safe, as effective, and performance is substantially equivalent to the predicate devices. |
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GE Healthcare 510(k) Premarket Notification Submission
5
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6
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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 script, enclosed within a circular shape. The circle is made up of swirling lines, giving it a dynamic and fluid appearance. The logo is presented in a blue color.