Optima XR240amx

K162990 · Ge Medical Systems, LLC · IZL · Nov 15, 2016 · Radiology

Device Facts

• Record ID: K162990
• Device Name: Optima XR240amx
• Applicant: Ge Medical Systems, LLC
• Product Code: IZL · Radiology
• Decision Date: Nov 15, 2016
• 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.

Device Story

Battery-operated mobile X-ray system; generates diagnostic radiographic images for detection of disease or injury (e.g., orthopedic damage, tumors, pneumonia). Inputs: X-ray exposures captured via film, CR, or wireless flat-panel detectors. Operation: System uses WiFi (802.11) to communicate with cleared wireless detectors; synchronizes image acquisition and retrieval; processes images for display. Used in clinical settings (OR, ICU, ER) by healthcare providers. Output: Digital radiographic images viewed by clinicians to inform diagnostic and treatment decisions. Benefits: Enables bedside imaging for immobile or critically ill patients; provides high-quality images with reduced dose compared to traditional CR.

Clinical Evidence

Bench testing only. No clinical studies were required as the incorporated wireless detectors possess their own 510(k) clearances. Verification and validation included risk analysis, requirements/design reviews, module/system integration testing, and simulated use testing to confirm safety and effectiveness.

Technological Characteristics

Battery-operated mobile X-ray system. Features WiFi (802.11) wireless communication for detector pairing and image transfer. Supports multiple detector sizes (17x14 inch, 10x12 inch). Includes detector storage bin and charging hardware. Software handles image acquisition, processing, and user interface updates. Complies with voluntary standards for safety and performance.

Indications for Use

Indicated for adult and pediatric patients for general-purpose diagnostic radiographic examinations of the skull, spinal column, chest, abdomen, and extremities. Used in clinical environments including emergency, ICU, NICU, cardiac, and OR departments where patient transport is impractical or unsafe. Not for mammography.

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 XR200amx and Optima XR220amx (K142383)

Reference Devices

• PerkinElmer, Inc. XRpad2 3025 HWC-M Flat Panel Detector (K161942)
• PerkinElmer, Inc. XRpad2 4336 HWC-M Flat Panel Detector (K161966)

Submission Summary (Full Text)

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

November 15, 2016

GE Healthcare GE Medical Systems, LLC % Mr. Chris Paulik Regulatory Affairs Program Manager 3000 N. Grandview Blvd. WAUKESHA WI 53188

Re: K162990

Trade/Device Name: Optima XR240amx Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MQB Dated: October 26, 2016 Received: October 27, 2016

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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Sincerely yours.

Michael D'Hara

For 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 (FORM FDA 3881) Section 4:

Optima XR240amx

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## Indications for Use

510(k) Number (if known)

## K162990

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 seff-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, 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)

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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# 510(k) Summary

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

| Date: | October 26, 2016 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems, LLC |
| | 3000 N. Grandview Blvd |
| | Waukesha, WI 53188, USA |
| Primary<br>Contact<br>Person: | Chris Paulik |
| | Regulatory Affairs Program Manager |
| | GE Healthcare |
| | 262-548-2010 |
| | [e-mail] |
| Secondary<br>Contact<br>Person: | Diane Uriell |
| | Regulatory Affairs Director |
| | GE Healthcare |
| | 262-290-8218 |
| | [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 |
| | Regulation: 21 CFR 892.1720 |
| | Classification: Class II |
| | Product Codes: IZL, MQB |
| Predicate<br>Device(s): | Optima XR200amx and Optima XR220amx (K142383) |
| | 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). |
| | 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 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. |
| | The incorporation of cleared flat panel detectors provides increased<br>functionality to enable images of patients of all sizes, and can produce<br>comparable quality images with as little as half the dose of traditional<br>computer radiography (CR), cassettes and other flat panel detectors with<br>lower DQE. |
| | The systems are 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. |
| | These devices are 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<br>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…