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.

Device Description

The Optima XR240amx 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).

The Optima XR240amx 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 wireless RFID Reader and the associated software into the Optima XR240amx allows the user to gain access to the system using an RFID badge that has been assigned to them by the clinic or hospital that has employed them. This feature can be used in lieu of entering a physical User ID and Password into the Optima XR240amx user interface. In conjunction, the RFID reader will grant the user access to the drive control in lieu of entering a unique hardcoded pin on the Optima XR240amx user interface.

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.

AI/ML Overview

This 510(k) summary (device K182234) for the Optima XR240amx mobile X-ray system primarily addresses the incorporation of an optional wireless RFID reader and associated software. The submission aims to demonstrate substantial equivalence to its predicate device (Optima XR240amx with AutoGrid, K173602).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with reported device performance for the primary function of X-ray imaging. Instead, it focuses on demonstrating that the modifications (incorporation of the RFID reader) do not negatively impact the existing safety and effectiveness of the device.

The "Determination of Substantial Equivalence" section lists compliance with various voluntary standards as a measure of meeting safety and performance requirements for the modified device:

Acceptance Criteria (Compliance with Standards)	Reported Device Performance
ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance	"The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "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."
IEC 60601-1-3 Medical Elec. Equipment - P. 1: General Req. for Safety 3. Collateral Standard: General Req. for Radiation Protection in Diagnostic XRay Equipment	"The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "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."
IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for safety - Collateral Standard: Usability	"The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "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."
IEC 60601-2-54 Medical electrical equipment - Part 2- 54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy	"The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "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."
IEC 62366 Medical devices - Application of usability engineering to medical Devices	"The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "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."
PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) set. (Radiology)	"The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "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."
AIM Standard 7351731 - Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers	"The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "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."
Risk Analysis and Mitigation Verification	"New risks were identified for incorporating the wireless RFID Reader and associated software into the Optima XR240amx. These risks were mitigations were verified and validated as a part of the design verification and validation testing that has been executed with acceptable results."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "The subject of this premarket submission, Optima XR240amx, did not require clinical studies to support substantial equivalence of incorporating an RFID Reader into the system to gain access to the system."

Therefore, there is no information provided about a "test set" in the context of clinical or imaging data, nor its sample size or provenance. The testing focused on engineering verification and validation of the RFID reader integration and its impact on the system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical studies with a test set requiring expert ground truth were conducted for this specific submission. The assessment was primarily engineering-based.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical studies with a test set requiring adjudication were conducted for this specific submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for an X-ray system with an RFID reader, not an AI-assisted diagnostic device. Therefore, no MRMC comparative effectiveness study was performed or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This submission is for an X-ray system with an RFID reader, not a standalone algorithm. The RFID reader is a user authentication and access control mechanism, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical studies with a test set requiring ground truth were conducted for this specific submission. The ground truth for the engineering verification and validation would be adherence to specified design requirements, functionality, and safety standards, as verified through testing.

8. The sample size for the training set

Not applicable, as there is no mention of a training set. This submission is for hardware/software modification, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)	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:

DateSubmitted:	August 10, 2017
Submitter:	GE Medical Systems, LLC3000 N. Grandview BlvdWaukesha, WI 53188, USA
PrimaryContactPerson:	Chris PaulikRequlatory Affairs ManagerGE Healthcare262-548-2010Christopher.A.Paulik@ge.com
SecondaryContactPerson:	Diane UriellRegulatory Affairs DirectorGE Healthcare262-290-8218Diane.Uriell@ge.com
Device TradeName:	Optima XR240amx
Common/UsualName:	Mobile X-ray system
Regulation,Classification,and ProductCode:	Regulation Name: Mobile X-Ray SystemRegulation: 21 CFR 892.1720Classification: Class IIProduct Codes: IZL, MQB
PredicateDevice(s):	Optima XR240amx with AutoGrid (K173602)
	Regulation Name: Mobile X-Ray System
	Regulation: 21 CFR 892.1720
	Classification: Class II
	Product Codes: IZL, MQB
DeviceDescription:	The Optima XR240amx is intended to take exposures, using a wired orremote exposure switch, utilizing film, computed radiography (CR), orcleared wireless radiographic detectors, which are intended to replaceradiographic film screen systems in all general purpose diagnosticprocedures, for digital radiography (DR).Optima XR240amx is a self-contained; battery operated mobileradiographic imaging system designed to generate diagnosticradiographic images (medical x-rays) that may increase the ability todetect disease or injury early enough for a medical problem to bemanaged, treated, or cured. Medical x-rays are used in many types ofexaminations and procedures, some examples include: x-rayradiography (to find orthopedic damage, tumors, pneumonias, foreignobjects).The Optima XR240amx system is indicated for use on adult and pediatricpatients for general-purpose diagnostic radiographic examinations andprocedures. Its mobility enables general-purpose radiographicprocedures throughout the clinical environment, or as needed within theemergency, intensive care, premature birth ward, cardiac and operatingdepartments, for patients that may not be able to be moved or in caseswhere it is unsafe or impractical to move them to a traditional RADroom.The incorporation of an optional wireless RFID Reader and theassociated software into the Optima XR240amx allows the user to gainaccess to the system using an RFID badge that has been assigned tothem by the clinic or hospital that has employed them. This feature canbe used in lieu of entering a physical User ID and Password into theOptima XR240amx user interface. In conjunction, the RFID reader willgrant the user access to the drive control in lieu of entering a uniquehardcoded pin on the Optima XR240amx user interface.The system is indicated for taking radiographic exposures of the skull,spinal column, chest, abdomen, extremities, and other body parts withthe patient sitting, standing, or lying in the prone or supine position.This device is not intended for mammographic applications.
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 purposediagnostic procedures, for digital radiography (DR).
	Optima XR240amx is a self-contained; battery operated mobileradiographic imaging system designed to generate diagnosticradiographic images (medical x-rays) that may increase the ability todetect disease or injury early enough for a medical problem to bemanaged, treated, or cured. Medical x-rays are used in many types ofexaminations and procedures, some examples include: x-rayradiography (to find orthopedic damage, tumors, pneumonias, foreignobjects).
	The Optima XR240amx is indicated for use on adult and pediatricpatients for general-purpose diagnostic radiographic examinations andprocedures. Its mobility enables general-purpose radiographicprocedures throughout the clinical environment, or as needed within theemergency, intensive care, premature birth ward, cardiac and operatingdepartments, for patients that may not be able to be moved or in caseswhere it is unsafe or impractical to move them to a traditional RADroom.
	The system is indicated for taking radiographic exposures of the skull,spinal column, chest, abdomen, extremities, and other body parts withthe 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 optionalimage processing software installed as a part of the systems Heliximage processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic imagesby reducing the effects of scatter radiation.
Technology:	The Optima XR240amx employs the same fundamental scientifictechnology as the predicate device. They are both battery operatedmobile x-ray systems that capture exposures utilizing film, CR plates, ora wireless detector. The intended use is the same between the OptimaXR240amx and the predicate device. The Optima XR240amx did notchange the input power, battery subsystem, drive subsystem, x-raygeneration, and exposure control from the predicate devices. Thedifference being introduced is a modification to the hardware andsoftware to incorporate an optional wireless RFID reader. This RFIDreader allows the user to gain access to the system using an RFID badgethat has been assigned to them by the clinic or hospital that hasemployed them. This feature can be used in lieu of entering a physicalUser ID and Password into the Optima XR240amx user interface. Inconjunction, the RFID reader will grant the user access to the drivecontrol in lieu of entering a unique hardcoded pin on the OptimaXR240amx user interface.
	The software on the Optima XR240amx has been modified toincorporate the encoding of the specific RFID badge provided to anauthorized user that has been assigned to them by the clinic or hospitalthat has employed them. Subsequently, the user can gain access to thesystem using their unique RFID badge as if they had entered their uniqueuser ID and password.
Determinationof SubstantialEquivalence:	Summary of Non-Clinical Tests:The modification to the Optima XR240amx to include a RFID Reader andits applications comply with voluntary standards:ES60601-1 Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance ; IEC 60601-1-3 Medical Elec. Equipment - P. 1: General Req. for Safety3. Collateral Standard: General Req. for Radiation Protection inDiagnostic XRay Equipment ; IEC 60601-1-6 Medical electrical equipment - Part 1-6: Generalrequirements for safety - Collateral Standard: Usability ; IEC 60601-2-54 Medical electrical equipment - Part 2- 54: Particularrequirements for the basic safety and essential performance of X-rayequipment for radiography and radioscopy ; IEC 62366 Medical devices - Application of usability engineering tomedical Devices ; PS 3.1 - 3.20 Digital Imaging and Communications in Medicine(DICOM) set. (Radiology). AIM Standard 7351731 - Medical Electrical Equipment and SystemElectromagnetic Immunity Test for Exposure to Radio FrequencyIdentification Readers The following quality assurance measures were applied to thedevelopment 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 andassociated software into the Optima XR240amx. These risks were
	mitigations were verified and validated as a part of the designverification and validation testing that has been executed withacceptable results.
	Summary of Clinical Tests:
	The subject of this premarket submission, Optima XR240amx, did notrequire clinical studies to support substantial equivalence ofincorporating an RFID Reader into the system to gain access to thesystem.
	Design verification and validation testing was performed to confirm thatthe safety and effectiveness of the device has not been affected. Thetest plans and results have been executed with acceptable results.
Conclusion:	The Optima XR240amx incorporates an RFID reader and its associatedsoftware to allow an authorized user to gain access to the system usingtheir unique ID badge that has been assigned to them by the clinic orhospital that has employed them in lieu of entering a unique User ID andpassword. This update to this system does not result in any newpotential safety risks, it has the same technological characteristics, andperform as well as the devices currently on the market.
	After analyzing design verification and validation testing on the bench itis the conclusion of GE Healthcare that the Optima XR240amx to be assafe, as effective, and performance is substantially equivalent to thepredicate 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.

Regulation Number and Section

§ 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.