(79 days)
Not Found
No
The summary describes a standard digital radiography system and does not mention any AI or ML capabilities, image processing beyond basic display and storage, or performance studies related to AI/ML metrics.
No
The device is described as a digital radiography system used for diagnostic imaging, not for treating any condition or disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device acquires X-ray images "for diagnostic purposes," and the "Device Description" section mentions that "the diagnosis is performed" using the displayed images.
No
The device description clearly describes a digital radiography system with physical components like X-ray tubes and detectors, indicating it is a hardware-based medical device.
Based on the provided information, 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 Description: The description clearly states that the EOS is a "digital radiography system" that uses X-rays to generate images of the patient's body. This is an in vivo diagnostic method, meaning it is performed on a living organism.
- Intended Use: The intended use describes the acquisition of radiographic images for diagnostic purposes, which is consistent with an in vivo imaging system.
The device is a medical imaging system used for diagnostic purposes, but it does not involve testing samples taken from the body, which is the defining characteristic of an IVD.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
EOS is designed to conform with IEC 60601-1 and collateral standards. A 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 appropriate dosing and image quality. Software verification and validation testing was also conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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510(k) SUMMARY
EOS imaging's EOS
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
FEB 2 2 2013
EOS imaging 10 rue Mercoeur PARIS F-75011 FRANCE
Phone: + 33 1 55 25 60 60 Facsimile: + 33 1 55 25 60 61
.
Karine Chevrie, Quality and Regulatory Affairs Officer Contact Person:
Date Prepared: December 5, 2012
Name of Device and Name/Address of Sponsor:
EOS EOS imaging 10 rue Mercoeur PARIS F-75011 FRANCE
Common or Usual Name: Digital Radiography System
Classification Name: Radiology
Predicate Devices: EOS imaging's EOS (K120721; K071546)
Purpose of the Special 510(k) notice:
The 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.
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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. A 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 appropriate dosing and image quality. Software verification and validation 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 22, 2013
EOS Imaging C/O John J. Smith, M.D., J.D. Hogan Lovells US L.L.P. 555 Thirteenth Street, NW Washington, DC, 20004
Re: K123740
Trade/Device Name: EOS Regulation Number: 21 CFR 892.1650 Regulation Name: Image Intensified Fluoroscopic X-Ray system Regulatory Class: Class II Product Code: MQB Dated: December 5, 2012 Received: December 5, 2012
Dear Dr. 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 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
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Page 2 -- [Dr. Smith]
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.
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 Diagnostics and Radiological Health 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,
Image /page/3/Figure/5 description: The image shows a logo with the letters "FDA" in a stylized, interconnected design. The letters are formed by a series of parallel lines that create a three-dimensional effect. The overall design is intricate and abstract, with the letters blending together to form a cohesive shape.
for
Janine M. Morris Director Division of Radiolgoical Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123740
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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
FSA
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K123740 510(k)
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