(265 days)
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No
The document describes standard digital radiography technology and image manipulation software, but there is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
No.
The device is described as a "Direct Digital Radiography Upgrade unit" that captures and converts X-ray images to digital images for diagnostic purposes, not for treating any condition.
No
The device is described as an upgrade unit that captures and converts X-ray images, producing "a diagnostic image." It is explicitly stated that the UDI 1717 "cannot be used for Mammography applications," but it does not perform diagnosis itself. Instead, it provides the images from which a diagnosis can be made.
No
The device description explicitly mentions a "17" x 17" sensor plate," which is a hardware component used for capturing images. This indicates the device is not solely software.
Based on the provided text, the UDI 1717 System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The UDI 1717 System directly captures and converts X-ray images of the human body itself, not specimens taken from the body.
- The intended use describes capturing and converting X-ray images for diagnostic purposes. This is a form of medical imaging, not in vitro diagnostics.
The description clearly indicates the device is used for Direct Digital Radiography, which is an imaging modality, not an in vitro diagnostic method.
N/A
Intended Use / Indications for Use
The UDI 1717 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UDI 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" sensor plate capture large patient imaging and areas.
For the review of parts of the anatomy (legs, spine, etc.) that exceed the panel's dimensions, several Images can also be "stitched" together to allow the review of this part of the anatomy as one single image.
The UDI 1717 cannot be used for Mammography applications.
Product codes
MQB
Device Description
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Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
X-ray
Anatomical Site
legs, spine, general radiographic application
Indicated Patient Age Range
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Intended User / Care Setting
hospitals, clinics and imaging centers
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three curved lines representing its wings or feathers.
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
MAY 2 2 2012
Ms. Ariel Marciano Director, Operations Meridian Medical Systems, LLC 325 Harris Drive AURORA OH 44202 -
Re: K112527
Trade/Device Name: Universal Digital Interface (UDI) 1717 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: April 17, 2012 Received: April 17, 2012
Dear Ms. Marciano:
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
1
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 withication. 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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4. INDICATION FOR USE
Applicant: Meridian Medical Systems
510(k) Number (if known): K112527
Device Name: Universal Digital Interface (UDI) 1717
Indication For Use: The UDI 1717 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UDI 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" sensor plate capture large patient imaging and areas.
For the review of parts of the anatomy (legs, spine, etc.) that exceed the panel's dimensions, several Images can also be "stitched" together to allow the review of this part of the anatomy as one single image.
The UDI 1717 cannot be used for Mammography applications.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE).
hmy D'Khm
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112527