(20 days)
Not Found
No
The document mentions "image processing software" (AutoGrid) but does not explicitly state or imply the use of AI or ML techniques within this software or any other part of the device. The focus is on standard radiographic imaging and an optional RFID reader for access.
No
Explanation: The device is described as a diagnostic radiographic imaging system intended for generating medical x-rays to detect disease or injury. It does not provide treatment.
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 an X-ray generator, detectors (film, CR, wireless), and an optional RFID Reader. While it includes software components like AutoGrid and RFID access software, it is fundamentally a hardware system with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Optima XR240amx is an X-ray imaging system. It generates medical x-rays to create images of the internal structures of the body. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "general purpose diagnostic radiographic procedures" and "taking radiographic exposures of the skull, spinal column, extremities, and other body parts". 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 Diagnostics.
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 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.
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray radiography
Anatomical Site
skull, spinal column, extremities, and other body parts; 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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Optima XR240amx with AutoGrid (K173602)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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
1
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
2
Indications for Use
510(k) Number (if known)
K182234
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 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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3
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Section 5: 510(k) Summary
Optima XR240amx
4
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date
| Submitted: | August 10, 2017 |
|---|---|
| Submitter: | GE Medical Systems, LLC |
| 3000 N. Grandview Blvd | |
| Waukesha, WI 53188, USA | |
| Primary | |
| Contact | |
| Person: | Chris Paulik |
| Requlatory Affairs 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 XR240amx with AutoGrid (K173602) |
| 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 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. |
| 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. |
| | 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. |
| Technology: | The Optima XR240amx employs the same fundamental scientific
technology as the predicate device. They are both battery operated
mobile x-ray systems that capture exposures utilizing film, CR plates, or
a wireless detector. The intended use is the same between the Optima
XR240amx and the predicate device. 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 is a modification to the hardware and
software to incorporate an optional wireless RFID reader. This RFID
reader 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 software on the Optima XR240amx has been modified to
incorporate the encoding of the specific RFID badge provided to an
authorized user that has been assigned to them by the clinic or hospital
that has employed them. Subsequently, the user can gain access to the
system using their unique RFID badge as if they had entered their unique
user ID and password. |
| Determination
of Substantial
Equivalence: | Summary of Non-Clinical Tests:
The modification to the Optima XR240amx to include a RFID Reader and
its applications comply with voluntary standards:
ES60601-1 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance ; 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 ; IEC 60601-1-6 Medical electrical equipment - Part 1-6: General
requirements for safety - Collateral Standard: Usability ; 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 ; IEC 62366 Medical devices - Application of usability engineering to
medical Devices ; PS 3.1 - 3.20 Digital Imaging and Communications in Medicine
(DICOM) set. (Radiology). AIM Standard 7351731 - Medical Electrical Equipment and System
Electromagnetic Immunity Test for Exposure to Radio Frequency
Identification Readers 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 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. |
| | Summary of Clinical Tests: |
| | 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. |
| | 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 incorporates an RFID reader and its associated
software to allow an authorized user to gain access to the system using
their unique ID badge that has been assigned to them by the clinic or
hospital that has employed them in lieu of entering a unique User ID and
password. 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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GE Healthcare 510(k) Premarket Notification Submission
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7
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8
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.