(104 days)
Not Found
No
The description focuses on the hardware and basic digital imaging capabilities, with no mention of AI or ML algorithms for image processing, analysis, or diagnosis.
No.
The "Intended Use" states that the device is for "general radiographic examinations and applications" and "allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes." This indicates it is a diagnostic imaging device, not one that provides therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device allows "the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes." Additionally, the "Device Description" mentions that "the diagnosis is performed" using the displayed images.
No
The device description clearly outlines hardware components including X-ray tubes, digital detectors, and a monitor, indicating it is a physical medical device system, not software-only.
No, 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 (within the living body) imaging technique, not an in vitro test.
- Intended Use: The intended use is for "general radiographic examinations and applications" and the acquisition of "X-ray images for diagnostic purposes." This aligns with medical imaging, not laboratory testing of samples.
The device is a medical imaging device, specifically a type of X-ray system.
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
KPR, MOB
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. The diagnostic images are stored in a 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. This device employs the same technological characteristics as the predicate devices differing only in the specifics of subassembly component composition.
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
Additional testing confirmed the equivalent performance of the EOS as compared to the claimed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K013999, K973908, K790692, K945278, K843926, K020635, K983732
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
Biospace Med's EOS
SEP 1 8 2007
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Biospace Med 10 rue Mercoeur Paris F-75011 France
Phone: +33 1 55 25 60 60 Facsimile: +33 1 55 25 60 61
Contact Person:Karine Chevrie
Date Prepared: June 5, 2007
Trade Name: EOS
Common or Usual Name: Digital Radiography System
Classification Name: Radiology
Predicate Devices
- The Lodox Digital Radiography System (K013999) .
- . Toshiba's Auklet CT scanner TSX-003-A (K973908)
- GE Televix 1600 (K790692) with AGFA Cornex 5 film .
- Philips Bucky Diagnost System (K945278) with AGFA Curix-Ortho HT-G film .
- CGR Prestilix (K843926) + Kodak DirectView CR 900 System (K020635) .
- Siemens DR Thorax/Multix FD (K983732) ◆
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.
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. The diagnostic images are stored in a 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. This device employs the same technological characteristics as the predicate devices differing only in the specifics of subassembly component composition.
Performance Data
EOS is designed to comply with IEC 60601-1 and collateral standards.
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Additional testing confirmed the equivalent performance of the EOS as compared to the claimed predicate devices.
Substantial Equivalence
EOS is as safe and effective as conventional radiography systems. EOS has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between EOS and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that EOS is as safe and effective as common radiography systems. Thus, EOS is substantially equivalent.
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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
Biospace Med % Mr. John J. Smith Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004
AUG 2 0 2013
Re: K071546
Trade/Device Name: EOS Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: August 9, 2007 Received: August 10, 2007
Dear Mr. Smith:
This letter corrects our substantially equivalent letter of September 18, 2007.
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
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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 nredicate 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
KO71546 510(k) Number (if known):_
Device Name: EOS
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 AND/OR (Part 21 C.F.R. 801 Subpart D)
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
CDRH, Office of Device Evaluation (ODE)
Concurrence of
Hubert Leinen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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