(29 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the hardware and basic digital imaging process without mentioning any advanced analytical or learning capabilities.
No
The device is used for diagnostic imaging (acquiring X-ray images) and not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the EOS allows X-ray image acquisition "for diagnostic purposes." Additionally, the "Device Description" mentions that "The diagnostic images are stored in a local database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed." These statements clearly indicate its role in diagnosis.
No
The device description clearly describes a digital radiography system with physical components like X-ray tubes, detectors, and a scanning mechanism, indicating it is a hardware device with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general radiographic examinations and applications" and describes the acquisition of X-ray images for "diagnostic purposes." This involves imaging the patient's body directly.
- Device Description: The device description details a "digital radiography system" that uses X-ray tubes and detectors to generate images of the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are the defining characteristics of an IVD.
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is an imaging system used to visualize the internal structures of the body directly.
N/A
Intended Use / Indications for Use
The EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography and mammography. EOS allows the radiographic acquisition of either one or two orthogonal X ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.
Product codes
MQB
Device Description
EOS is a digital radiography system in which two sets of xenon gas filled digital detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. The diagnostic images are stored in a local database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing and archiving. The fundamental technological characteristics of the modified EOS are unchanged compared to the cleared EOS.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
whole body or a reduced area of investigation
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
EOS is designed to conform with IEC 60601-1 and collateral standards. An IECEE CB (certification body) test certificate has been issued. Additional performance and functional testing has confirmed the equivalent performance of the modified EOS compared to the EOS. This testing included bench testing to confirm equivalent resolution and accuracy of the modified EOS, and mechanical resistance testing of the stabilization accessory. Software verification testing was also conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) SUMMARY
APR - 6 2012
EOS imaging's EOS
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
EOS imaging 10 rue Mercoeur PARIS F-75011 FRANCE
- 33 1 55 25 60 60 Phone: Facsimile: + 33 1 55 25 60 61
Contact Person: Karine Chevrie, Quality and Regulatory Affairs Officer
April 4, 2012 Date Prepared:
Name of Device and Name/Address of Sponsor:
EOS EOS imaging 10 rue Mercoeur PARIS F-75011 FRANCE
Digital Radiography System Common or Usual Name:
Classification Name: Radiology
Predicate Devices: EOS imaging's EOS (K071546)
Purpose of the Special 510(k) notice.
The modified EOS is a modification to the cleared EOS.
Intended Use
The EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography and mammography. EOS allows the radiographic acquisition of either one or two orthogonal X ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.
1
Technological Characteristics
EOS is a digital radiography system in which two sets of xenon gas filled digital detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. The diagnostic images are stored in a local database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing and archiving. The fundamental technological characteristics of the modified EOS are unchanged compared to the cleared EOS.
Performance Data
EOS is designed to conform with IEC 60601-1 and collateral standards. An IECEE CB (certification body) test certificate has been issued. Additional performance and functional testing has confirmed the equivalent performance of the modified EOS compared to the EOS. This testing included bench testing to confirm equivalent resolution and accuracy of the modified EOS, and mechanical resistance testing of the stabilization accessory. Software verification testing was also conducted.
Substantial Equivalence
The modified EOS has the same intended use and similar indications, principles of operation, and technological characteristics as the cleared EOS. The minor differences in the modified EOS's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the modified EOS is as safe and effective as the cleared EOS. Thus, the modified EOS is substantially equivalent to its predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another figure, represented by three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
) L
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
APR - 6 2012
EOS Imaging % Mr. John Smith Regulatory Counsel Hogan Lovells US L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K120721
Trade/Device Name: EOS Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: March 8, 2011 Received: March 8, 2011
Dear Mr. Smith:
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 or any I vathan 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
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Janine M. Morris
Acting 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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Indications for Use Statement
510(k) Number (if known):_
Device Name: EOS
Indications for Use:
The EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography and mammography. EOS allows the radiographic acquisition of either one or two orthogonal X ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.
Prescription Use __ x (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use_ (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K