(30 days)
Not Found
No
The summary describes a mobile radiographic imaging system and its intended use, focusing on hardware and basic functionality. There is no mention of AI, ML, or advanced image processing that would typically indicate the presence of such technology. The performance studies focus on safety and basic functionality, not algorithmic performance metrics.
No.
The device is a mobile radiographic imaging system designed to generate diagnostic images to detect disease or injury, not to provide therapy or treatment.
Yes
The device is explicitly stated as being "designed to generate diagnostic images (medical x-rays)" and is "indicated for general-purpose diagnostic radiographic examinations and procedures."
No
The device description clearly states it is a "mobile radiographic imaging system" that generates "diagnostic radiographic images (medical x-rays)" and utilizes hardware components like a "GE Wireless Detector" and a "flat panel detector". This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Optima XR200amx and Optima XR220amx are described as mobile radiographic imaging systems that generate diagnostic images (medical x-rays) by taking exposures of the patient's body. This is an in vivo diagnostic procedure, meaning it is performed on a living organism.
- No mention of samples: The text does not mention the device analyzing any samples taken from the body.
Therefore, the device's function and the description provided clearly indicate it is a medical imaging device used for in vivo diagnostic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
IZL
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).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray radiography
Anatomical Site
skull, spinal column, extremities, chest, abdomen, and other body parts.
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
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 XR200amx and Optima XR220amx and their 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 risk were identified for potential user error or misuse attributed with the addition of the remote hand switch. 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 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.
Design verification and validation testing was performed to confirm that the safety and effectiveness of the devices has not been affected. The test plans and results have been executed with acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Brivo XR285amx, Optima XR200amx, and Optima XR220amx K103476
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines connecting them.
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.
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.
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
2
Indications for Use
510(k) Number (if known)
Device Name Optima XR200amx and Optima XR220amx
Indications for Use (Describe)
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.
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)
3
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Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance. The logo is simple, yet iconic, representing the brand's long history and global presence.
Attachment A: Section 5 – 510(k) Summary
| Document Name | Document
Number | 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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Image /page/6/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.
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, LLC |
| 3000 N. Grandview Blvd | |
| Waukesha, WI 53188, USA | |
| Primary Contact Person: | Chris Paulik |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| 262-548-2010 | |
| Christopher.Paulik@med.ge.com | |
| Secondary Contact Person: | John L. Schmidt |
| Regulatory Affairs Manager | |
| GE Healthcare | |
| 262-548-4964 | |
| John.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 892.1720 |
| IZL | |
| Predicate Device(s): | Brivo XR285amx, Optima XR200amx, and Optima XR220amx |
| K103476 | |
| 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). | |
| 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. | |
| Intended Use: 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 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 series 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, 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. |
| Technology: | The Optima XR200amx and Optima XR220amx employ the same
fundamental scientific technology as the predicate devices. The only
difference is that exposures can now be initiated using either a wired or
remote exposure switch. |
| Determination
of Substantial
Equivalence: | Summary of Non-Clinical Tests:
The Optima XR200amx and Optima XR220amx and their 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 risk were identified for potential user error or misuse attributed with
the addition of the remote hand switch. 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 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.
Design verification and validation testing was performed to confirm that
the safety and effectiveness of the devices has not been affected. The test
plans and results have been executed with acceptable results. |
| Conclusion: | The Optima XR200amx and Optima XR220amx devices incorporate a
wired as well as a remote hand switch for the user to initiate x-ray
exposures. The addition of the optional wireless hand switch to these
systems do not result in any new potential safety risks, they have 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 XR200amx and Optima
XR220amx to be as safe, as effective, and performance is substantially | |
| equivalent to the predicate devices. | |
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Image /page/7/Picture/1 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 frame. The frame is made up of curved lines that resemble stylized leaves or flourishes. The logo is colored in a bright, solid blue.
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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.
9
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.