Optima XR240amx

K182234 · Ge Medical Systems, LLC · IZL · Sep 6, 2018 · Radiology

Device Facts

• Record ID: K182234
• Device Name: Optima XR240amx
• Applicant: Ge Medical Systems, LLC
• Product Code: IZL · Radiology
• Decision Date: Sep 6, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Optima XR240amx 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). Optima XR240amx 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 Optima XR240amx 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 Optima XR240amx 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.

Device Story

Optima XR240amx is a battery-operated mobile radiographic imaging system; captures diagnostic x-ray images using film, CR, or wireless digital detectors. Used in clinical settings (emergency, ICU, OR) by clinicians for patients unable to be moved to fixed RAD rooms. System includes optional AutoGrid software to improve image contrast by reducing scatter radiation. New feature: optional wireless RFID reader allows authorized users to access system and drive controls via RFID badge in lieu of manual ID/password or PIN entry. Healthcare providers use images to detect orthopedic damage, tumors, pneumonia, or foreign objects, facilitating clinical management and treatment. Device mobility benefits patients by enabling bedside imaging.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including module verification, integration testing, performance testing, safety testing, and simulated use validation.

Technological Characteristics

Battery-operated mobile x-ray system. Components: x-ray generator, wireless/wired detectors, optional RFID reader. Standards: ES60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-54, IEC 62366, DICOM (PS 3.1-3.20), AIM Standard 7351731. Software: Helix image processing software with optional AutoGrid for scatter reduction.

Indications for Use

Indicated for adult and pediatric patients requiring general-purpose diagnostic radiographic examinations of the skull, spinal column, chest, abdomen, and extremities. Used in clinical environments including emergency, ICU, NICU, cardiac, and operating departments where patient transport is impractical or unsafe. Contraindicated for mammographic applications.

Regulatory Classification

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.

Predicate Devices

• Optima XR240amx with AutoGrid (K173602)

Submission Summary (Full Text)

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September 6, 2018

GE Medical Systems, LLC % Chris Paulik Regulatory Affairs Management 3000 N. Grandview Blvd. WAUKESHA, WI 53188

Re: K182234

Trade/Device Name: Optima XR240amx Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB Dated: August 10, 2018 Received: August 17, 2018

Dear Mr. Chris Paulik:

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/cfpmn/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

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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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Hsl 2. Nils

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)

#### K182234

Device Name Optima XR240amx

#### Indications for Use (Describe)

The Optima XR240amx 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).

Optima XR240amx 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 Optima XR240amx is indicated for use on adult and pediatic 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, 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 Optima XR240amx 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) |
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| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5: 510(k) Summary

Optima XR240amx

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# 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date<br>Submitted: | August 10, 2017 |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems, LLC<br>3000 N. Grandview Blvd<br>Waukesha, WI 53188, USA |
| Primary<br>Contact<br>Person: | Chris Paulik<br>Requlatory Affairs Manager<br>GE Healthcare<br>262-548-2010<br>[e-mail] |
| Secondary<br>Contact<br>Person: | Diane Uriell<br>Regulatory Affairs Director<br>GE Healthcare<br>262-290-8218<br>[e-mail] |
| Device Trade<br>Name: | Optima XR240amx |
| Common/Usual<br>Name: | Mobile X-ray system |
| Regulation,<br>Classification,<br>and Product<br>Code: | Regulation Name: Mobile X-Ray System<br>Regulation: 21 CFR 892.1720<br>Classification: Class II<br>Product Codes: IZL, MQB |
| Predicate<br>Device(s): | Optima XR240amx with AutoGrid (K173602) |
| | Regulation Name: Mobile X-Ray System |
| | Regulation: 21 CFR 892.1720 |
| | Classification: Class II |
| | Product Codes: IZL, MQB |
| Device<br>Description: | The Optima XR240amx is intended to take exposures, using a wired or<br>remote exposure switch, utilizing film, computed radiography (CR), or<br>cleared wireless radiographic detectors, which are intended to replace<br>radiographic film screen systems in all general purpose diagnostic<br>procedures, for digital radiography (DR).<br><br>Optima XR240amx is a self-contained; battery operated mobile<br>radiographic imaging system designed to generate diagnostic<br>radiographic images (medical x-rays) that may increase the ability to<br>detect disease or injury early enough for a medical problem to be<br>managed, treated, or cured. Medical x-rays are used in many types of<br>examinations and procedures, some examples include: x-ray<br>radiography (to find orthopedic damage, tumors, pneumonias, foreign<br>objects).<br><br>The Optima XR240amx system is indicated for use on adult and pediatric<br>patients for general-purpose diagnostic radiographic examinations and<br>procedures. Its mobility enables general-purpose radiographic<br>procedures throughout the clinical environment, or as needed within the<br>emergency, intensive care, premature birth ward, cardiac and operating<br>departments, for patients that may not be able to be moved or in cases<br>where it is unsafe or impractical to move them to a traditional RAD<br>room.<br><br>The incorporation of an optional wireless RFID Reader and the<br>associated software into the Optima XR240amx allows the user to gain<br>access to the system using an RFID badge that has been assigned to<br>them by the clinic or hospital that has employed them. This feature can<br>be used in lieu of entering a physical User ID and Password into the<br>Optima XR240amx user interface. In conjunction, the RFID reader will<br>grant the user access to the drive control in lieu of entering a unique<br>hardcoded pin on the Optima XR240amx user interface.<br><br>The system is indicated for taking radiographic exposures of the skull,<br>spinal column, chest, abdomen, extremities, and other body parts with<br>the patient sitting, standing, or lying in the prone or supine position.<br><br>This device is not intended for mammographic applications. |
| Intended Use: | The Optima XR240amx is intended to take exposures utilizing film,<br>computed radiography (CR), or wireless detectors which are intended to |
| | replace radiographic film screen systems in all general purpose<br>diagnostic procedures, for digital radiography (DR). |
| | Optima XR240amx is a self-contained; battery operated mobile<br>radiographic imaging system designed to generate diagnostic<br>radiographic images (medical x-rays) that may increase the ability to<br>detect disease or injury early enough for a medical problem to be<br>managed, treated, or cured. Medical x-rays are used in many types of<br>examinations and procedures, some examples include: x-ray<br>radiography (to find orthopedic damage, tumors, pneumonias, foreign<br>objects). |
| | The Optima XR240amx is indicated for use on adult and pediatric<br>patients for general-purpose diagnostic radiographic examinations and<br>procedures. Its mobility enables general-purpose radiographic<br>procedures throughout the clinical environment, or as needed within the<br>emergency, intensive care, premature birth ward, cardiac and operating<br>departments, for patients that may not be able to be moved or in cases<br>where it is unsafe or impractical to move them to a traditional RAD<br>room. |
| | The system is indicated for taking radiographic exposures of the skull,<br>spinal column, chest, abdomen, extremities, and other body parts with<br>the patient sitting, standing, or lying in the prone or supine position. |
| | This device is not intended for mammographic applications. |
| | The Optima XR240amx incorporates AutoGrid, which is an optional<br>image processing software installed as a part of the systems Helix<br>image processing software. AutoGrid can be used in lieu of an anti-<br>scatter grid to improve image contrast in general radiographic images<br>by reducing the effects of scatter radiation. |
| Technology: | The Optima XR240amx employs the same fundamental scientific<br>technology as the predicate device. They are both battery operated<br>mobile x-ray systems that capture exposures utilizing film, CR plates, or<br>a wireless detector. The intended use is the same between the Optima<br>XR240amx and the predicate device. The Optima XR240amx did not<br>change the input power, battery subsystem, drive subsystem, x-ray<br>generation, and exposure control from the predicate devices. The<br>difference being introduced is a modification to the hardware and<br>software to incorporate an optional wireless RFID reader. This RFID<br>reader allows the user to gain access to the system using an RFID badge<br>that has been assigned to them by the clinic or hospital that has<br>employed them. This feature can be used in lieu of entering a physical<br>User ID and Password into the Optima XR240amx user interface. In<br>conjunction, the RFID reader will grant the user access to the drive<br>control in lieu of entering a unique hardcoded pin on the Optima<br>XR240amx user interface. |
| | The software on the Optima XR240amx has been modified to<br>incorporate the encoding of the specific RFID badge provided to an<br>authorized user that has been assigned to them by the clinic or hospital<br>that has employed them. Subsequently, the user can gain access to the<br>system using their unique RFID badge as if they had entered their unique<br>user ID and password. |
| Determination<br>of Substantial<br>Equivalence: | Summary of Non-Clinical Tests:<br>The modification to the Optima XR240amx to include a RFID Reader and<br>its applications comply with voluntary standards:<br>ES60601-1 Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance ; IEC 60601-1-3 Medical Elec. Equipment - P. 1: General Req. for Safety<br>3. Collateral Standard: General Req. for Radiation Protection in<br>Diagnostic XRay Equipment ; IEC 60601-1-6 Medical electrical equipment - Part 1-6: General<br>requirements for safety - Collateral Standard: Usability ; IEC 60601-2-54 Medical electrical equipment - Part 2- 54: Particular<br>requirements for the basic safety and essential performance of X-ray<br>equipment for radiography and radioscopy ; IEC 62366 Medical devices - Application of usability engineering to<br>medical Devices ; PS 3.1 - 3.20 Digital Imaging and Communications in Medicine<br>(DICOM) set. (Radiology). AIM Standard 7351731 - Medical Electrical Equipment and System<br>Electromagnetic Immunity Test for Exposure to Radio Frequency<br>Identification Readers The following quality assurance measures were applied to the<br>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) New risks were identified for incorporating the wireless RFID Reader and<br>associated software into the Optima XR240amx. These risks were |
| | mitigations were verified and validated as a part of the design<br>verification and validation testing that has been executed with<br>acceptable results. |
| | Summary of Clinical Tests: |
| | The subject of this premarket submission, Optima XR240amx, did not<br>require clinical studies to support substantial equivalence of<br>incorporating an RFID Reader into the system to gain access to the<br>system. |
| | Design verification and validation testing was performed to confirm that<br>the safety and effectiveness of the device has not been affected. The<br>test plans and results have been executed with acceptable results. |
| Conclusion: | The Optima XR240amx incorporates an RFID reader and its associated<br>software to allow an authorized user to gain access to the system using<br>their unique ID badge that has been assigned to them by the clinic or<br>hospital that has employed them in lieu of entering a unique User ID and<br>password. This update to this system does not result in any new<br>potential safety risks, it has the same technological characteristics, and<br>perform as well as the devices currently on the market. |
| | After analyzing design verification and validation testing on the bench it<br>is the conclusion of GE Healthcare that the Optima XR240amx to be as<br>safe, as effective, and performance is substantially equivalent to the<br>predicate devices. |

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# GE Healthcare 510(k) Premarket Notification Submission

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Image /page/8/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular shape. The circular shape has decorative swirls around the letters. The logo is blue.