(129 days)
Not Found
No
The summary describes a medical display device and does not mention any AI or ML capabilities.
No
The device is described as a "diagnostic display" intended to display and view digital images for review and analysis, which are diagnostic functions, not therapeutic ones.
Yes
The 'Device Description' specifically states: "The Nova - Radiology Monochrome Display is a diagnostic display."
No
The device description explicitly states it is a "Radiology Monochrome Display," which is a hardware component. The intended use also describes displaying and viewing digital images, which requires a physical display.
Based on the provided information, the Nova Radiology Medical Displays are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "display and view digital images for review and analysis by trained medical practitioners." This describes a device used for visualizing medical images, not for performing tests on biological samples.
- Device Description: It's described as a "diagnostic display," which aligns with image viewing, not in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information about a patient's health status based on laboratory tests
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Nova Radiology Medical Displays are used in vivo (within the body, indirectly) by displaying images acquired from the body.
Therefore, the Nova Radiology Medical Displays fall under the category of medical imaging display devices, not IVDs.
N/A
Intended Use / Indications for Use
The Nova Radiology Medical Displays are intended to be used to display and view digital images for review and analysis by trained medical practitioners. The Nova 5MP display is currently not cleared in the U.S. for use with Full Field Digital Mammography (FFDM). The Nova 1MP, 2MP and 3MP displays are not intended for use with FFDM.
Product codes
90LLZ
Device Description
The Nova - Radiology Monochrome Display is a diagnostic display. The Nova Radiology Monochrome Display is a high resolution, Liquid Crystal Display (LCD) with mgn resoration, Exquery Exquery and analysis of high-resolution medical images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K023340, K023322, K032202, K013922, K032638, K023341
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
KO40310
JUN 1 7 2004
510(k) Summary
| A. Manufacturer: | National Display Systems, Inc
16245 Vineyard Boulevard
Morgan Hill, CA 95037
USA |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Submitted By: | Ron Hansen
Product Manager
National Display System, Inc. |
| C. Date of Preparation: | June 15, 2004 |
| D. Contact Information: | Tel: 408.776.0085 Ext. 128
Fax: 408.776.9878 |
| E. Classification Name: | System, image processing |
| F. Common Name: | Monitor, display, and others |
| G. Proprietary Name: | Nova - Radiology 18.1" Monochrome Display (1MP)
Nova - Radiology 20.1" Monochrome Display (2MP)
Nova - Radiology 20.8" Monochrome Display (3MP) and
Nova - Radiology 21.3" Monochrome Display (5MP) |
| H. Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| I. Substantial Equivalence: | Nova 1MP = Coronis 1MP (Barco) K023340
Nova 2MP = Coronis 2MP (Barco) K023322 and Dome C2 (Planar Systems) K032202
Nova 3MP = Coronis 3MP (Barco) K013922 and Dome C3 (Planar Systems) K032638
Nova 5MP = Coronis 5MP (Barco) K023341 and Dome C5i (Planar Systems) K032202 |
| J. Device Description: | The Nova - Radiology Monochrome Display is a
diagnostic display. |
| K. Intended Use: | The Nova Radiology Medical Displays are intended to be
used to display and view digital images for review and
analysis by trained medical practitioners. The Nova 5MP
display is currently not cleared in the U.S. for use with Ful
Field Digital Mammography (FFDM). The Nova 1MP,
2MP and 3MP displays are not intended for use with
FFDM |
1
- The Nova Radiology Monochrome Display is a L. Technological Characteristics: high resolution, Liquid Crystal Display (LCD) with mgn resoration, Exquery Exquery and analysis of high-resolution medical images.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design featuring three overlapping lines that resemble an abstract representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Mr. Ron Hansen Product Manager National Display Systems, Inc. 16245 Vinevard Blvd. MORGAN HILL CA 95037
Re: K040310 Trade/Device Name: NOVA Family of Medical Radiology Displays Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: May 28, 2004 Received: June 2, 2004
Dear Mr. Hansen:
We have reviewed your Section 510(k) premarket notification of intent to market the device WE have reviewed your becalled is substantially equivalent (for the indications felerenced above and navo user. International marketed predicate devices marketed in interstate for use stated in the encrosary to togethy to together the Medical Device Amendments, or to Conniered phor to May 20, 1978, 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 I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of motice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classinod (600 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affe may be subject to satil additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the 0000 cerments 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 that I DA has made a determinations administered by other Federal agencies. You must comply of ally I each a statures and regulations as but not limited to: registration and listing (21 CFR Part with an the Free Prequirements) ; good manufacturing practice requirements as set forth in the 807), laocimig (21 CFR Part 820), good and if applicable, the electronic product quality Systems (QD) regans (Sections 531-542 of the Act), 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hanteling your antial equivalence of your device to a legally premarket notification. The PDA miding of bactification 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 Part 801), please If you desire specific advice for your deville following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of the promote the regulation entitled, "Misbranding Office of Compliance at (301) 37 1-1007.97) you may obtain. Other general by reletence to premarket notification (er the Act may be obtained from the Division of Small Information on your responsional Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Bryden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K040310
Device Name: NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS
Indications for Use:
The Nova Radiology Medical Displays are intended to display and view digital images for review and analysis by trained model Pied Digital Mammography (FFDM). The currently not cleared in the U.S. for use with First and with FFDM.
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 Device Evaluation (ODE)
David R. Seymon
510k) Nu
Page 1 of ____________________________________________________________________________________________________________________________________________________________________