(19 days)
No
The summary describes a mobile radiographic imaging system and its intended use, device description, and performance studies. There is no mention of AI or ML technology being incorporated into the device's functionality or image processing. The focus is on the hardware (x-ray generation, detectors) and basic image acquisition and transfer.
No
The device is a radiographic imaging system intended for diagnostic procedures to detect disease or injury, not to cure or treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed to generate diagnostic radiographic images (medical x-rays)" and is indicated for "general-purpose diagnostic radiographic examinations and procedures."
No
The device description clearly states it is a "self-contained; battery operated mobile radiographic imaging system" and mentions hardware components like "wireless radiographic detectors" and a "wired or remote exposure switch." This indicates it is a physical hardware device, not software only.
Based on the provided text, the Optima XR240amx is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the Optima XR240amx is a mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) of the patient's body parts (skull, spinal column, extremities, chest, abdomen, etc.). It does not involve the analysis of biological samples.
- The device description focuses on generating images using x-rays. The core function is to produce radiographic images, not to perform tests on in vitro samples.
- The intended use is for general-purpose diagnostic radiographic examinations and procedures. This involves imaging the patient directly, not analyzing samples from the patient.
Therefore, the Optima XR240amx falls under the category of medical imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for 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, 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.
Product codes
IZL, MQB
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).
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 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 cleared flat panel detectors 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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Skull, spinal column, extremities, and other body parts (including chest, abdomen)
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Clinical environment, emergency, intensive care, premature birth ward, cardiac and operating departments.
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 Optima XR240amx and its applications comply with voluntary standards. The following quality assurance measures 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 risks were identified for incorporating wireless image transfer between the cleared wireless detector and the base system. 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, Optima XR240amx, did not require clinical studies to support substantial equivalence for the incorporation WiFi (802.11) enabled detectors due to these detectors having their own 510(k) clearance. The detectors used to verify and validate the Optima XR240amx were the PerkinElmer, Inc. XRpad2 3025 HWC-M Flat Panel Detector cleared under K161942 and the PerkinElmer, Inc. XRpad2 4336 HWC-M Flat Panel Detector cleared under K161966.
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 Optima XR240amx device incorporates cleared radiographic detectors to capture radiographic images and utilizes a tether or wireless technology to transfer the images to the base system. 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 Optima XR240amx to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Optima XR200amx and Optima XR220amx (K142383)
Reference Device(s)
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.
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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.
1
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.
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
3
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)
4
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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 | |
| Contact | |
| Person: | Chris Paulik |
| Regulatory Affairs Program Manager | |
| GE Healthcare | |
| 262-548-2010 | |
| Christopher.A.Paulik@ge.com | |
| Secondary | |
| Contact | |
| Person: | Diane Uriell |
| Regulatory Affairs Director | |
| GE Healthcare | |
| 262-290-8218 | |
| Diane.Uriell@ge.com | |
| Device Trade | |
| Name: | Optima XR240amx |
| 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 XR200amx and Optima XR220amx (K142383) |
| Regulation Name: Mobile X-Ray System | |
| Regulation: 21 CFR 892.1720 | |
| Classification: Class II | |
| Product Codes: IZL, MQB | |
| 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). | |
| 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 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 cleared flat panel detectors 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 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. | |
| 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. | |
| Technology: The Optima XR240amx employs the same fundamental scientific
technology as the predicate devices. They are both battery operated
mobile x-ray systems that capture exposures utilizing film, CR plates, or
a wireless detector. The intended use and the indications for use are the
same between the Optima XR240amx and the predicate devices. The
Optima XR240amx did not change the input power, battery subsystem,
drive subsystem, x-ray generation, and exposure control from the
predicate devices. The difference being introduced with the Optima
XR240amx is that exposures can be captured with cleared detectors of
multiple sizes. These cleared detectors utilize WiFi (802.11) instead of
Ultra Wideband (UWB) technology to transfer the image to the base
system. To accommodate the cleared wireless detectors, the Optima
XR240amx changed the following from the predicate devices:
Wireless communication hardware for detector communication was changed from UWB to WiFi (802.11) Detector storage bin geometry and its associated detector charging hardware and firmware to accommodate multiple sized cleared wireless detectors (17 inch x 14 inch; 10 inch x 12 inch) System software to accomplish the following: WiFi (802.11) association and pairing with the cleared wireless detectors Synchronizing the image acquisition and image retrieval from the cleared wireless detectors Image processing algorithms to accommodate multiple image matrix sizes User interface updates for image acquisition to incorporate the cleared wireless detectors into the user workflow | |
| | |
| Determination
of Substantial
Equivalence: | Summary of Non-Clinical Tests: |
| | The Optima XR240amx and its applications comply with voluntary
standards. The following quality assurance measures 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 risks were identified for incorporating wireless image transfer
between the cleared wireless detector and the base system. 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, Optima XR240amx, did not
require clinical studies to support substantial equivalence for the
incorporation WiFi (802.11) enabled detectors due to these detectors
having their own 510(k) clearance. The detectors used to verify and
validate the Optima XR240amx were the PerkinElmer, Inc. XRpad2 3025
HWC-M Flat Panel Detector cleared under K161942 and the PerkinElmer,
Inc. XRpad2 4336 HWC-M Flat Panel Detector cleared under K161966. |
| | 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 Optima XR240amx device incorporates cleared radiographic
detectors to capture radiographic images and utilizes a tether or
wireless technology to transfer the images to the base system. 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 Optima XR240amx to be as
safe, as effective, and performance is substantially equivalent to the
predicate devices. |
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