UNIVERSAL DIGITAL INTERFACE (UDI) 1717

K112527 · Meridian Medical Systems, LLC · MQB · May 22, 2012 · Radiology

Device Facts

• Record ID: K112527
• Device Name: UNIVERSAL DIGITAL INTERFACE (UDI) 1717
• Applicant: Meridian Medical Systems, LLC
• Product Code: MQB · Radiology
• Decision Date: May 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended 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.

Device Story

UDI 1717 is a Direct Digital Radiography (DR) upgrade system; converts conventional X-ray source projections into digital images. Input: X-ray radiation captured by 17" x 17" sensor plate. Output: Digital diagnostic images displayed on computer monitor. Features include image manipulation software and stitching capability for large anatomy (e.g., legs, spine). Used in hospitals, clinics, and imaging centers by radiology staff. Eliminates film/cassette processing; enables digital storage, printing, and electronic transmission. Benefits include reduced time and costs associated with traditional film radiography.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technological comparison to existing legally marketed devices.

Technological Characteristics

Direct Digital Radiography (DR) system; 17" x 17" sensor plate; stationary X-ray system; digital image acquisition and processing; software-based image manipulation and stitching; connectivity for printing/emailing. Excludes mammography.

Indications for Use

Indicated for general radiographic imaging applications in hospitals, clinics, and imaging centers. Suitable for large patient imaging areas using a 17" x 17" sensor plate. Supports image stitching for anatomy exceeding panel dimensions. Contraindicated for mammography.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

{0}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{2}------------------------------------------------

## 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