(148 days)
Not Found
No
The summary describes a diagnostic monitor for displaying images and mentions image processing, but there is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on the display capabilities and compliance with safety standards.
No
The device is a diagnostic monitor used for viewing medical images, not for treating or preventing disease. Its function is to display information for medical practitioners, not to administer therapy.
No
The device is a monitor used for viewing and analyzing radiography images, not for performing diagnostic procedures itself.
No
The device description clearly states it is a "widescreen 30-inch 10 megapixel grayscale diagnostic monitor," indicating it is a hardware device.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Model S10 is a display monitor used for viewing and analyzing radiography images. Radiography images are generated by external imaging equipment (like X-ray machines) and are not samples taken from the body.
- Intended Use: The intended use is for displaying and viewing images for review and analysis by medical practitioners, not for performing tests on biological samples.
The device is a medical device, specifically a diagnostic display monitor, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Model S10 is intended for use in displaying and viewing radiography images for review and analysis by trained medical practitioners, and for use in mammography display systems.
Product codes
LLZ
Device Description
The Dome S10 is a widescreen 30 -inch 10 megapixel grayscale diagnostic monitor. Its sleek design and high brightness makes the S10 ideal for viewing full field digital mammography and allow it to show two 5MP images for back-to-back chest wall reads.
Mentions image processing
Image Processing.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiography images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the logo for NDS Surgical Imaging. The logo consists of a grid of squares on the left, followed by the letters "NDS" in large, bold font. Below the letters, the words "SURGICAL IMAGING" are printed in a smaller font. The logo is black and white.
KB2770
Page 1 of 2
JAN 30 2014
510(K) SUMMARY
A. Manufacturer:
B. Submitted By:
Jim Leng Regulatory Engineer/NDS Surgical Imaging, LLC
Bl, Address:
NDS Surgical Imaging, LLC 5750 Hellyer Avenue San Jose, CA 95138 USA.
Picture Archiving Communication System
System. Image Processing. Radiological
NDS Surgical Imaging. LLC
408-776-0085
408-776-9878
The Dome® $10 Color Monitor
5750 Hellver Avenue San Jose, CA 95138
USA
์Tel:
Fax:
LLZ
C. Date of Preparation: July 18. 2013
D. Contact Information:
E. Classification:
F. Common Name:
G. Proprietary Name:
H. Classification Number: 21 CFR 892.2050
I Product Code:
J. Substantial Equivalence:
Model S10 is substantial equivalent to the predicate device K093197 Coronis Fusion 10MP (MDCG-10130). Both devices have the same indication for use with the same characteristics. Both devices use same technology and use displays with the same resolution, same number of colors, same refresh rate, same maximum brightness, and the same pixel rise/fall times. The few minor cosmetic differences do not impact display information and viewing.
- K. Device Description: The Dome S10 is a widescreen 30 -inch 10 megapixel gravscale diagnostic monitor. Its sleek design and high brightness makes the S10 ideal for viewing full field digital mammography and allow it to show two 5MP images for back-to-back chest wall reads.
GRADIANCE ADOME
1
Image /page/1/Picture/0 description: The image shows the logo for NDS Surgical Imaging. The logo consists of a grid of squares on the left, followed by the letters "NDS" in a bold, sans-serif font. Below the letters, the words "SURGICAL - IMAGING" are printed in a smaller font. The logo is black and white.
Родегов
.
- GRADIANCE PADOME
| L. Intended Use: | The Model S10 is intended for use in displaying and viewing
radiography images for review and analysis by trained medical
practitioners, and for use in mammography display systems. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| M. Technological Characteristics: | Bezel-free framing of 10 megapixels of data is presented in a landscape
format with resolution of 4096 x 2560 and a pixel pitch of 0.158mm. 1024
intrinsic shades of gray with programmable gamma yield a palette of up to
4096 shades. The integrated Dome RightLight Controller monitors and
stabilizes backlight luminance. The display unit includes a PCI Express
graphics board to support the required dual-link connectivity for the
display. |
| N. Conclusion: | Based upon our test results, the model S10 radiology display meets
IEC/EN60601-1 and 60601-1-2 standards which establish its safe design
and operation. And both the model S10 and the predicate device Coronis
Fusion 10MP (MDCG-10130) are identical in terms of indication for use,
characteristics, specifications and performance. |
:
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, creating a clear and recognizable emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
January 30, 2014
NDS Surgical Imaging, LLC % Mr. Jim Leng Regulatory Engineer 5750 Hellyer Avenue SAN JOSE CA 95138
Re: K132770
Trade/Device Name: Dome S10 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 16, 2014 Received: January 22, 2014
Dear Mr. Leng:
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.
3
Page 2-Mr. Leng
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/Safetv/ReportaProblem/dcfault.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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
K132770 510/k) Niimher lif known !
Digital Flat-Panel Display System, Model: S10
Indications for Use (Describe)
The Model S10 is intended for use in displaying and viewing radiography images for review and analysis by trained medical practitioners, and for use in mammography display systems.
Type of Use (Select one or both. as applicable)
Prescription Use (Part 21 CFR 801 Subper. J)
J Over-The-Counter Use (21 CFR 801 Subpan C)
Please do not write below this line - continue on a separate page if needed.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
FORM FDA 3881 (1/14)
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7:5 Pat 10:24 10:20 10:143-04-4 1 17
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