(86 days)
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No
The document describes a medical display device and does not mention any AI or ML capabilities. The focus is on displaying digital images for review.
No
The device is a medical display used for viewing and analyzing digital images, not for treating a disease or condition.
Yes
Explanation: The "Device Description" explicitly states, "The AXIS Monochrome Display is a diagnostic display."
No
The device description explicitly states it is a "high resolution, Liquid Crystal Display (LCD) with electronic capabilities," indicating it is a hardware device.
Based on the provided information, 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 AXIS Radiology Monochrome Medical Displays are described as devices used to display and view digital images for review and analysis. They are essentially monitors designed for medical imaging.
- Lack of Biological Sample Interaction: The description does not mention any interaction with biological samples or performing any tests on them. The input is "digital images," not biological specimens.
- Intended Use: The intended use is for displaying and viewing existing digital images, not for performing diagnostic tests on biological samples.
Therefore, the AXIS Radiology Monochrome Medical Displays fall under the category of medical imaging display devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The AXIS Monochrome Medical Displays are intended to be used to display and view digital images for review and analysis by trained medical practitioners. The AXIS V (5MP) display is currently not cleared in the U.S. for use with Full Field Digital Mammography (FFDM). The AXIS I (1MP), AXIS II (2MP) and AXIS III (3MP) displays are not intended for use with FFDM.
Product codes (comma separated list FDA assigned to the subject device)
90LLZ
Device Description
The AXIS Monochrome Display is a diagnostic display. The AXIS Monochrome Display is a high resolution, Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images.
Mentions image processing
System, image processing
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained medical practitioners
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.
K040310, K023340, K023322, K032202, K013922, K032638, K023341
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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K04-2353
NOV 2 4 2004 510(k) Summary National Display Systems, Inc A. Manufacturer: 16245 Vineyard Boulevard Morgan Hill, CA 95037 USA B. Submitted By: Ron Hansen Product Manager National Display System, Inc. C. Date of Preparation: August 18, 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: AXIS I Monochrome Display (1MP) AXIS II Monochrome Display (2MP) AXIS III Monochrome Display (3MP) and AXIS V Monochrome Display (5MP) 21 CFR 892.2050/Procode 90LLZ H. Classification Number: Substantial Equivalence: I.
| AXIS I (1MP) | = Nova 1MP (NDS) K040310 and Coronis 1MP (Barco) K023340 |
|---|---|
| AXIS II (2MP) | = Nova 2MP (NDS) K040310; Coronis 2MP (Barco) K023322 and |
| Dome C2 (Planar Systems) K032202 | |
| AXIS III (3MP) | = Nova 3MP (NDS) K040310; Coronis 3MP (Barco) K013922 and |
| Dome C3 (Planar Systems) K032638 | |
| AXIS V (5MP) | = Nova 5MP (NDS) K040310; Coronis 5MP (Barco) K023341 and |
| Dome C5i (Planar Systems) K032202 | |
| J. Device Description: | The AXIS Monochrome Display is a diagnostic display. |
| K. Intended Use: | The AXIS Monochrome Medical Displays are intended to |
| be used to display and view digital images for review and | |
| analysis by trained medical practitioners. The AXIS V | |
| (5MP) display is currently not cleared in the U.S. for use | |
| with Full Field Digital Mammography (FFDM). The AXIS |
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I (1MP), AXIS II (2MP) and AXIS III (3MP) displays are not intended for use with FFDM.
- L. Technological Characteristics: The AXIS Monochrome Display is a high resolution, Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized emblem resembling a bird or abstract human figure, with three curved lines forming its body. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem. The text and emblem are both in black, set against a white background.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2004
Mr. Ron Hansen Product Manager National Display Systems, Inc. 16245 Vineyard Blvd. MORGAN HILL CA 95037
Re: K042353 Trade/Device Name: AXIS I (1MP), II (2MP), III (3MP), and V (5MP) Monochrome Displays Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems
Regulatory Class: II Product Code: 90 LLZ Dated: October 20, 2004 Received: October 25, 2004
Dear Mr. Hansen:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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.
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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 premated 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmaldsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): N/A
Device Name: AXIS FAMILY OF MEDICAL RADIOLOGY MONOCHROME DISPLAYS
Indications for Use:
The AXIS Radiology Monochrome Medical Displays are intended to be used to display and view digital images for review and analysis by trained medical practitioners. The AXIS 5MP display is currently not cleared in the U.S. for use with Full Field Digital Mammography (FFDM). The AXIS 1MP, 2MP and 3MP displays are not intended for use 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)
Nancy Hogdon
(Division Sign-Off)
Abdomi Division of Reproductive and Radiological Devices 510(k) Number _
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