(26 days)
Not Found
No
The summary describes a digital radiography system with image processing improvements but does not mention AI, ML, or related concepts.
No.
The device is an imaging system used for diagnostic purposes, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "EOS allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes." The "Device Description" also 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 use in diagnosing.
No
The device description clearly states that EOS is a "digital radiography system" with "two sets of xenon gas filled digital detectors and X-ray tubes," which are hardware components. The summary also mentions "bench testing to confirm appropriate dosing and image quality," further indicating the presence of hardware. While software is involved for image processing and display, the core device is a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that EOS is a digital radiography system that uses X-rays to create images of the patient's body. It does not involve analyzing samples taken from the body.
- Intended Use: The intended use is for general radiographic examinations and assessing skeletal deformities, which are diagnostic procedures performed directly on the patient using imaging technology.
Therefore, EOS falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, 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.
The Micro Dose feature is indicated for imaging with a patient entrance dose of 10 to 90 µGy for assessing global skeletal deformities in follow-up pediatric examinations. Micro Dose is not indicated for focal skeletal abnormalities and/or other pediatic abnormalities. Micro Dose is not indicated for use in patients with a Body Mass Index over 30.
Product codes
KPR
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. An acquisition feature named Micro Dose allows image acquisition with a patient entrance dose of 10 to 90 uGv for assessing global skeletal deformities in follow-up pediatric exams. 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.
Mentions image processing
Yes
Improvement of image processing. The aim of this optimization is to increase the image contrast and dynamic during the image processing.
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
pediatric (for Micro Dose feature)
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)
Software verification and validation testing was also conducted. Additional performance and functional testing has confirmed the equivalent performance of the modified EOS compared to the cleared predicate EOS. This testing included bench testing to confirm appropriate dosing and image quality.
Performance testing has demonstrated that this modification allows reducing the entrance dose for the changed protocols, with maintaining equivalent or better image quality than the cleared EOS.
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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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 image of an eagle with its wings spread.
October 21, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
EOS Imaging % John J. Smith, M.D., J.D Partner Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K152788 Trade/Device Name: EOS System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: September 25, 2015 Received: September 25, 2015
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. 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,
Robert Oals
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
510(k) Number (if known)
K152788
Device Name
EOS System
Indications for Use (Describe)
EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, 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.
The Micro Dose feature is indicated for imaging with a patient entrance dose of 10 to 90 µGy for assessing global skeletal deformities in follow-up pediatric examinations. Micro Dose is not indicated for focal skeletal abnormalities and/or other pediatic abnormalities. Micro Dose is not indicated for use in patients with a Body Mass Index over 30.
Type of Use (Select one or both, as applicable)
X 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)
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510(k) SUMMARY
EOS imaginq's EOS System
EOS imaqing 10 rue Mercoeur PARIS F-75011 FRANCE
Phone: + 33 1 55 25 60 60 Facsimile: + 33 1 55 25 60 61
Contact Person: Mathias Breuil, Regulatory Affairs Project Leader
Date Prepared: October 13, 2015
Name of Device and Name/Address of Sponsor:
EOS System EOS imaging 10 rue Mercoeur PARIS F-75011 FRANCE Common or Usual Name: Digital Radiography System 21 CFR 892.1680; Stationary X-ray System Classification Name: Product Code KPR - System, X-Ray, Stationary Predicate Devices: K142773 cleared on January 22, 2015 Trade/Device Name: EOS System Regulation: 21 CFR 892.1680; Stationary X-Ray System Regulatory Class: II; Product Code: KPR, MQB
Intended Use/ indication for use
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.
The Micro Dose feature is indicated for imaging with a patient entrance dose of 10 to 90 µGv for assessing global skeletal deformities in follow-up pediatric examinations. Micro Dose is not indicated for focal skeletal abnormalities and/or other pediatric abnormalities. Micro Dose is not indicated for use in patients with a Body Mass Index over 30.
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. An acquisition feature named Micro Dose allows image acquisition with a patient entrance dose of 10 to 90 uGv for assessing global skeletal deformities in follow-up pediatric exams. 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.
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Performance Data
EOS is designed to conform to IEC 60601-1 and collateral standards. A CB (certification body) test certificate has been issued. Software verification and validation testing was also conducted. Additional performance and functional testing has confirmed the equivalent performance of the modified EOS compared to the cleared predicate EOS. This testing included bench testing to confirm appropriate dosing and image quality.
Substantial Equivalence
The modified EOS has the same intended use and similar indications, principles of operation, and technological characteristics as the cleared predicate device.
| | Modified EOS System
(K152788) | Comparison with cleared Predicate EOS System
(K142773) |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for Use | Both devices have the same intended use. | |
| Technological
Characteristics /
Principles of
Operation | The fundamental technological characteristics of the modified EOS are unchanged from
the cleared EOS. The modified EOS contains the following minor modifications that have
been implemented following the last clearance: | |
| • Hardware
Modifications | Component Supplier Changes | The change in suppliers has not resulted in any
changes to the design or manufacturing
specifications of the system. Performance and
functional testing has confirmed non-regression. |
| | Modification to electrical
components following
obsolescence | Components have been replaced with iso-functional
components. |
| | Mirror Sticker Accessory | New optional accessory kit |
| • Software
Modifications | Software modification related to a
recall action. | The acquisition software has been modified in order
to improve the detection of a dysfunction of the
spectral filter and to prevent the use of the system
after the alert message on spectral filtration
appears. |
| | Optimization of default acquisition
protocols | Performance testing has demonstrated that this
modification allows reducing the entrance dose for
the changed protocols, with maintaining equivalent
or better image quality than the cleared EOS. |
| | Improvement of image
processing. | The aim of this optimization is to increase the image
contrast and dynamic during the image processing. |
| | Addition of a new features like
Dose Structured Report and
Reject and Repeat Analysis
( | |
Conclusions
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 predicate device. Thus, the modified EOS is substantially equivalent to its predicate device.