(264 days)
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No
The summary describes standard digital radiography image capture and manipulation, with no mention of AI, ML, or related concepts.
No
The device is a diagnostic imaging device used to capture and convert X-ray images to digital format for viewing and analysis. It is not intended for therapeutic treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The result is a diagnostic image..." indicating that the images produced by the device are used for diagnostic purposes.
No
The device description explicitly mentions a "17" x 17" x 14" x 17" sensor plate," which is a hardware component used for image capture.
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 Function: The description clearly states that the UDI 2 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." This is an imaging device that captures images of the inside of the body using X-rays.
- No Sample Analysis: The device does not analyze any biological samples taken from a patient. It processes images generated by an external energy source (X-rays) passing through the body.
Therefore, based on the provided information, the UDI 2 System falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The UDI 2 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 connomar monitor, without the time and costs involved with the film or cassette handling. The image can has further manipulated on a the computer monitor via imaging software, can be printed and/or e-mailed. The DI 2 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" x 14" x 17" sensor plate captures large patient imaging and areas.
Product codes
MOB
Device Description
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Mentions image processing
The image can has further manipulated on a the computer monitor via imaging software, can be printed and/or e-mailed.
Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2014
Meridian Medical Systems, LLC % Mr. Larry Cornell Managing Director 325 Harris Drive AURORA OH 44202
Re: K140251
Trade/Device Name: Universal Digital Interface 2 (UDI 2) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 19, 2014 Received: September 22, 2014
Dear Mr. Cornell:
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.
Sm.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140251
Device Name Universal Digital Interface 2 (UDI 2)
Indications for Use (Describe)
The UDI 2 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 connomar monitor, without the time and costs involved with the film or cassette handling. The image can has further manipulated on a the computer monitor via imaging software, can be printed and/or e-mailed. The DI 2 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" x 14" x 17" sensor plate captures large patient imaging and areas.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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