(71 days)
Not Found
No
The summary describes a standard radiographic imaging device and does not mention any AI or ML capabilities in its intended use, device description, or performance studies.
No
The device is described as generating radiographic images for diagnostic purposes, not for treating any medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is intended for general-purpose diagnostic procedures."
No
The description clearly states the device is a radiographic imaging system ("generating radiographic images of human anatomy") and mentions generating images on film or digitally, implying hardware components for image acquisition. The predicate device is also a radiographic system, further supporting it's a hardware device.
Based on the provided information, the Optima XR120 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is for "generating radiographic images of human anatomy" for "general-purpose diagnostic procedures." This describes an in vivo diagnostic imaging device, not an in vitro diagnostic device.
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The Optima XR120 directly images the body itself.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- Mentions image processing, AI, DNN, or ML (Not Found): These are not directly relevant to whether a device is an IVD or not.
- Input Imaging Modality: "Radiographic images" is consistent with an in vivo imaging device.
- Anatomical Site: "human anatomy" is consistent with an in vivo imaging device.
- Performance Studies: The lack of clinical studies for substantial equivalence is common for imaging devices that are similar to existing ones, not necessarily indicative of an IVD.
In summary, the core function of the Optima XR120 is to create images of the inside of the body using X-rays, which is the definition of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Optima XR120 is indicated for use in generating radiographic images of human anatomy. It is intended for general-purpose diagnostic procedures. It is capable of generating images on film or digitally. This device is not intended for mammographic applications.
Product codes
IXL, MQB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic images
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
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
The subject of this premarket submission, Optima XR120, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
GE Definium AMX700, Model AMX 700 K052897
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1670 Spot-film device.
(a)
Identification. A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters and the circle are black, while the background is white.
JUL 1 9 2011
・ :
GE Healthcare 510(k) Premarket Notification Submission Optima XR120
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | May 6, 2011 |
| Submitter: | GE Healthcare, (GE Medical Systems, LLC) |
| 3000 N. Grandview Blvd. | |
| Waukesha, WI 53188 | |
| Primary Contact Person: | Nidhi Chaudhary |
| Regulatory Affairs Leader, X-Ray | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| Telephone: 414-721-2899; Fax: 414-918-8184 | |
| e-mail: Nidhi.Chaudhary@ge.com | |
| Secondary Contact Person: | David Blonski |
| Regulatory Affairs Director, X-Ray | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| Telephone: 262-513-4072; Fax: 262-364-2509 | |
| e-mail: David.Blonski@ge.com | |
| Device: | |
| Trade Name: | GE Healthcare Optima™ XR120 |
| Common/Usual Name: | Optima XR120 |
| Classification Names: | Optima XR120 |
| Product Code: | Class II, IZL, System, X-ray, Mobile, 21 CFR 892.1720 |
| Predicate Device(s): | GE Definium AMX700, Model AMX 700 K052897 |
| Intended Use: | The Optima XR120 is indicated for use in generating |
| radiographic images of human anatomy. It is intended for | |
| general-purpose diagnostic procedures. It is capable of | |
| generating images on film or digitally. This device is not | |
| intended for mammographic applications. |
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Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. There are three swirls around the outside of the circle.
GE Healthcare 510(k) Premarket Notification Submission Optima XR120
Technology:
Determination of
Substantial Equivalence:
The Optima XR120 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. 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)
The GE Healthcare Optima™ XR120 employs the same
fundamental scientific technology as its predicate devices.
- Safety testing (Verification) .
- . Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, Optima XR120, did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers the GE Healthcare Optima™ XR120 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is a stylized image of a human figure. To the right of the seal is the word "DEPAR".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Nidhi Chaudhary Regulatory Affairs Leader, X-ray GE Medical Systems, LLC 3000 N. Grandview Blvd. WAUKESHA WI 53188
Re: K111304
JUL 19 2011
Trade/Device Name: Optima XR120 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IXL and MQB Dated: May 7, 2011 Received: May 9, 2011
Dear Ms. Chaudhary:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure ·
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Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular frame. The frame has decorative swirls or flourishes around it. The logo is in black and white.
GE Healthcare
510(k) Premarket Notification Submission Optima XR120
510(k) Number (if known): K |II 304
Device Name: Optima XR120
Indications for Use:
The Optima XR120 is indicated for use in generating radiographic images of human anatomy. It is intended for general-purpose diagnostic procedures. It is capable of generating images on film or digitally. This device is not intended for mammographic applications.
Prescription Use_x (Part 21 CFR 801 Subpart D)
610
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety