(35 days)
The Nio 5MP (MDNG-6121) display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
Nio 5MP (MDNG-6121) display
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the Nio 5MP (MDNG-6121) display. This document does not contain information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, or other details typically found in a clinical study report or a more detailed technical submission.
Therefore, I cannot extract the requested information from this document. It primarily serves to state that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices for its indicated use.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.
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
Mr. Lieven De Wandel Regulatory Affairs Officer Barco NV Healthcare Division 35 President Kennedy Park KORTRIJK 8500 BELGIUM
JUL 2 3 2012
Re: K121788
Trade/Device Name: Nio 5MP (MDNG-6121) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 4, 2012 Received: June 18, 2012
Dear Mr. De Wandel:
We have reviewed your Section 510(k) premarket notification of intent to market the device w onave a sowe 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 for use stated in the enerobate) to 16gms actment date of the Medical Device Amendments, or to conniner of the ro 114) 20, 2011 11:11 in accordance with the provisions of the Federal Food, Drug, de vices that mave been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicrerer, mains 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 11 your device is exassified (ooo 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Drimal statutes and regulations administered by other Federal agencies. You must or ury 1 outer statutes and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 GBR-Patiss®01 and 809);amedical device reporting (reporting of
{1}------------------------------------------------
Page 2
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 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K121788
Device Name: Nio 5MP (MDNG-6121)
Indications for Use: The Nio 5MP (MDNG-6121) display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number_K121788
Page 1 of 1
N/A