The Optima XR200amx and Optima XR220amx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR220amx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

Optima XR200amx and Optima XR220amx are self-contained; battery operated mobile radiographic imaging systems designed to generate diagnostic 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 XR200amx and Optima XR220amx are 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 systems are 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.

These devices are not intended for mammographic applications.

Device Description

The Optima XR200amx and Optima XR220amx are intended to take exposures, using a wired or remote exposure switch, utilizing film or computed radiography (CR), however the Optima XR220amx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

Optima XR200amx and Optima XR220amx are self-contained; battery operated mobile radiographic imaging systems 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 XR200amx and Optima XR220amx systems are 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 to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room.

The flat panel detector provides increased functionality to enable images of patients of all sizes, and can produce comparable quality images with as little as half the dose of traditional computer radiography (CR), cassettes and other flat panel detectors with lower DQE. The digital detector is designed to withstand a distributed load of 352Lbs to accommodate certain larger patients.

The systems are 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.

These devices are not intended for mammographic applications.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to complete your request. The document is a 510(k) summary for the Optima XR200amx and Optima XR220amx mobile x-ray systems. It primarily focuses on demonstrating substantial equivalence to predicate devices and discusses general compliance with standards, risk analysis, and verification/validation testing for changes related to an optional wireless exposure switch.

Specifically, the document does not provide:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets or their data provenance.
Information on the number or qualifications of experts used for ground truth.
Details on adjudication methods.
Information on multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
Information on standalone algorithm performance.
The type of ground truth used (beyond implying general diagnostic image quality).
Sample size for training sets.
How ground truth for training sets was established.

The document states: "The subject of this premarket submission, Optima XR200amx and Optima XR220amx, did not require clinical studies to support substantial equivalence for the option of initiating x-ray exposures with the use of the remote exposure switch." This indicates that a study with acceptance criteria and detailed performance metrics as you requested was likely not performed or at least not included in this particular 510(k) summary because the focus was on demonstrating equivalence of a minor modification (the remote exposure switch).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 25, 2014

GE Medical Systems, LLC % Mr. Christopher Paulik Regulatory Affairs Leader 3000 N. Grandview Blvd. WAUKESHA WI 53188

Re: K142383

Trade/Device Name: Optima XR200amx, Optima XR220amx Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: August 22, 2014 Received: August 26, 2014

Dear Mr. 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. 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 (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.

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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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Sm. 7)

for

Janine M. Morris 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)

K142383

Device Name Optima XR200amx and Optima XR220amx

Indications for Use (Describe)

These devices are not intended for mammographic applications.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Attachment A: Section 5 – 510(k) Summary

Document Name	DocumentNumber	Page Number
Section 5 - 510(k) Summary	N/A	5 Pages

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Section 5: 510(k) Summary

Optima XR200amx and Optima XR220amx

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510(k) Summary

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

Date:	August 22, 2014
Submitter:	GE Medical Systems, LLC3000 N. Grandview BlvdWaukesha, WI 53188, USA
Primary Contact Person:	Chris PaulikRegulatory Affairs LeaderGE Healthcare262-548-2010Christopher.Paulik@med.ge.com
Secondary Contact Person:	John L. SchmidtRegulatory Affairs ManagerGE Healthcare262-548-4964John.L.Schmidt@med.ge.com
Device Trade Name:	Optima XR200amx and Optima XR220amx
Common/Usual Name:	Optima XR200amx and Optima XR220amx
Classification Names:Product Code:	Class II, System, X-ray, Mobile, 21 CFR 892.1720IZL
Predicate Device(s):	Brivo XR285amx, Optima XR200amx, and Optima XR220amxK103476
Device Description:	The Optima XR200amx and Optima XR220amx are intended to takeexposures, using a wired or remote exposure switch, utilizing film orcomputed radiography (CR), however the Optima XR220amx utilizes the GEWireless Detector, which is intended to replace radiographic film screensystems in all general purpose diagnostic procedures, for digitalradiography (DR).
operated mobile radiographic imaging systems designed to generatediagnostic radiographic images (medical x-rays) that may increase theability to detect 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-ray radiography(to find orthopedic damage, tumors, pneumonias, foreign objects).The Optima XR200amx and Optima XR220amx systems are indicated foruse on adult and pediatric patients for general-purpose diagnosticradiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, oras needed within the emergency, intensive care, premature birth ward,cardiac and operating departments, for patients that may not be able toto be moved or in cases where it is unsafe or impractical to move them to atraditional RAD room.The flat panel detector provides increased functionality to enable imagesof patients of all sizes, and can produce comparable quality images withas little as half the dose of traditional computer radiography (CR), cassettesand other flat panel detectors with lower DQE. The digital detector isdesigned to withstand a distributed load of 352Lbs to accommodatecertain larger patients.The systems are indicated for taking radiographic exposures of the skull,spinal column, chest, abdomen, extremities, and other body parts with thepatient sitting, standing, or lying in the prone or supine position.These devices are not intended for mammographic applications.
Intended Use: The Optima XR200amx and Optima XR220amx are intended to takeexposures utilizing film or computed radiography (CR), however the OptimaXR220amx utilizes the GE Wireless Detector, which is intended to replaceradiographic film screen systems in all general purpose diagnosticprocedures, for digital radiography (DR).Optima XR200amx and Optima XR220amx are self-contained; batteryoperated mobile radiographic imaging systems designed to generatediagnostic radiographic images (medical x-rays) that may increase theability to detect 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-ray radiography(to find orthopedic damage, tumors, pneumonias, foreign objects).The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Itsmobility enables general-purpose radiographic procedures throughout theclinical environment, or as needed within the emergency, intensive care,premature birth ward, cardiac and operating departments, for patientsthat may not be able to be moved or in cases where it is unsafe orimpractical to move them to a traditional RAD room.The systems are indicated for taking radiographic exposures of the skull
	spinal column, chest, abdomen, extremities, and other body parts with thepatient sitting, standing, or lying in the prone or supine position.These devices are not intended for mammographic applications.
Technology:	The Optima XR200amx and Optima XR220amx employ the samefundamental scientific technology as the predicate devices. The onlydifference is that exposures can now be initiated using either a wired orremote exposure switch.
Determinationof SubstantialEquivalence:	Summary of Non-Clinical Tests:The Optima XR200amx and Optima XR220amx and their applicationscomply with voluntary standards. The following quality assurancemeasures 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) New risk were identified for potential user error or misuse attributed withthe addition of the remote hand switch. These risks were reviewed andmitigated with design controls and labeling. The mitigations were verifiedand validated as a part of the design verification and validation testingthat has been executed with acceptable results.Summary of Clinical Tests:The subject of this premarket submission, Optima XR200amx and OptimaXR220amx, did not require clinical studies to support substantialequivalence for the option of initiating x-ray exposures with the use of theremote exposure switch.Design verification and validation testing was performed to confirm thatthe safety and effectiveness of the devices has not been affected. The testplans and results have been executed with acceptable results.
Conclusion:	The Optima XR200amx and Optima XR220amx devices incorporate awired as well as a remote hand switch for the user to initiate x-rayexposures. The addition of the optional wireless hand switch to thesesystems do not result in any new potential safety risks, they have the sametechnological characteristics, and perform as well as the devices currentlyon the market.
After analyzing design verification and validation testing on the bench it isthe conclusion of GE Healthcare that the Optima XR200amx and OptimaXR220amx to be as safe, as effective, and performance is substantially
equivalent to the predicate devices.

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Image /page/8/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 frame. The color of the logo is a light blue.

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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular shape. The circle is a light blue color.

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.