(19 days)
Not Found
No
The summary describes a medical display and software for optimizing image viewing, with no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as a display for reviewing digital images, a diagnostic rather than a therapeutic use.
No
The device is a display for reviewing digital images, specifically stated that it "must not be used in primary image diagnosis in mammography." This indicates it is not intended for diagnostic purposes, but rather for viewing.
No
The device description explicitly states that the device is a "19.0" color LCD display for medical viewing," which is a hardware component. While it includes software ("Niowatch"), it is not solely software.
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 MFCD 1219 and MFCD 1219 TS are described as display devices for viewing digital images. They are not performing tests on biological samples.
- Intended Use: The intended use is for displaying and reviewing digital images by trained medical practitioners. This is a function related to image interpretation, not laboratory testing.
- Lack of IVD-Specific Information: The provided information does not mention any biological samples, laboratory procedures, or diagnostic tests performed on those samples.
Therefore, the MFCD 1219 and MFCD 1219 TS fall under the category of medical imaging display devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
"The MFCD 1219 is intended to be used in displaying digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
"The MFCD 1219 TS is intended to be used in displaying digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammoqraphy.
"The MFCD 1219 is intended to be used in displaying and viewing digital images for review by The Fire CD 1223 is meetage must not be used in primary image diagnosis in mammography.
"The MFCD 1219 TS is intended to be used in displaying and viewing digital images for review by The Fire D 1213 Your international with the used in primary image diagnosis in mammography.
Product codes (comma separated list FDA assigned to the subject device)
90LLZ
Device Description
MFCD 1219 is a 19.0" color LCD display for medical viewing.
Niowatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.
The device consists of two components:
- One 1.3-megapixel flat panel display .
- . NioWatch software
The flat panel display has a resolution of 1280 x 1024 pixels.
The NioWatch software allows to set the display function, display test patterns, calibrate the display and view additional display and display controller information.
MFCD 1219 TS is a 19.0" color LCD display for medical viewing, equipped with a 19.0" touchscreen panel.
Niowatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.
The device consists of two components:
- One 1.3-meqapixel flat panel display .
- . NioWatch software
The flat panel display has a resolution of 1280 x 1024 pixels.
The NioWatch software allows to set the display test patterns, calibrate the display and view additional display and display controller information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners / Not Found
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): 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.
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.
Not Found
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).
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
510(k) Summary In accordance with 21 CFR 807.92
1. Date of preparation
SEP 2 8 2005
September 06, 2005
2. Company information
BarcoView 35 President Kennedypark B-8500 Kortrijk, Belgium Tel. +32-(0)56-233-211 Fax +32-(0)56-233-457
3. Contact person
Lieven De Wandel Official correspondent
4. Device information
- Trade name: MFCD 1219 .
- Common name: Medical flat panel display .
- Classification name: System, Image Processing .
- Classification number: 21 CFR 892.2050 / Procode 90LLZ .
5. Predicate device
- Name: MFCD 2320 .
- 510(k) number: K040158 .
- . Manufacturer: Barco NV
6. Device description
MFCD 1219 is a 19.0" color LCD display for medical viewing.
Niowatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.
7. Intended use
"The MFCD 1219 is intended to be used in displaying digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
8. Summary of technological characteristics
1
The device consists of two components:
- One 1.3-megapixel flat panel display .
- . NioWatch software
The flat panel display has a resolution of 1280 x 1024 pixels.
The NioWatch software allows to set the display function, display test patterns, calibrate the display and view additional display and display controller information.
Compared to the predicate device, MFCD 1219 has a different LCD panel with a somewhat smaller screen size and a lower resolution. The display has no built-in optical sensor and cannot be rotated into portrait orientation. The other components of the system are the same.
The device does not come into contact with the patient. It does not control any life sustaining devices either.
9. Conclusion:
The Barco MFCD 1219 is substantially equivalent to the predicate device, MFCD 2320.
The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use.
Any difference between both devices does not affect safety or efficacy.
The 510(k) Pre-Market Notification for the Barco MFCD 1219 contains adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device.
2
510(k) Summary In accordance with 21 CFR 807.92
1. Date of preparation
September 06, 2005
2. Company information
BarcoView 35 President Kennedypark B-8500 Kortrijk, Belgium Tel. +32-(0)56-233-211 Fax +32-(0)56-233-457
3. Contact person
Lieven De Wandel Official correspondent
4. Device information
- . Trade name: MFCD 1219 TS
- . Common name: medical flat panel display
- Classification name: System, Image Processing .
- Classification number: 21 CFR 892.2050 / Procode 90LLZ .
5. Predicate device
- Name: MFCD 2320 .
- 510(k) number: K040158 .
- Manufacturer: Barco NV .
6. Device description
MFCD 1219 TS is a 19.0" color LCD display for medical viewing, equipped with a 19.0" touchscreen panel.
Niowatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.
7. Intended use
"The MFCD 1219 TS is intended to be used in displaying digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammoqraphy.
3
8. Summary of technological characteristics
The device consists of two components:
- One 1.3-meqapixel flat panel display .
- . NioWatch software
The flat panel display has a resolution of 1280 x 1024 pixels.
The NioWatch software allows to set the display test patterns, calibrate the display and view additional display and display controller information.
Compared to the predicate device, MFCD 1219 TS has a different LCD panel with a somewhat smaller screen size and a lower resolution. The display has no built-in optical sensor and cannot be rotated into portrait orientation. Additionally, the MFCD 1219 TS display is equipped with a 19.0" touchscreen panel. The other components of the system are the same
The device does not come into contact with the patient. It does not control any life sustaining devices either.
9. Conclusion:
The Barco MFCD 1219 TS is substantially equivalent to the predicate device, MFCD 2320.
The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use.
Any difference between both devices does not affect safety or efficacy.
The 510(k) Pre-Market Notification for the Barco MFCD 1219 TS contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing the feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lieven De Wandel Official Correspondent Barco - Medical Imaging Systems President Kennedypark 35 B-8500 Kortrijk
SEP 2 8 2005
Re: K052478
Trade/Device Name: MFCD 1219 and MFCD 1219 TS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 6, 2005 Received: September 12, 2005
Dear Mr. De Wandel:
BELGIUM
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 rear 20, 1778, and colance 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 do not require approval brontrols 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 A poroval), it may be subject to such additional controls. Existing major regulations affecting your Appleo 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 I DA 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 r otes at building, 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.
5
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms leter with anow you to begin marketing of substantial equivalence of your device to a legally prematication: "The PDA mainly sification 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 derice on 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 notifications the Also, picase note the regulation entitled, "Theorial and on your responsibilities under the Act from the 807.97). Tou may outlin other general informations on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
6
INDICATIONS FOR USE
0(k) Number (if known): Kosz 478 ____________________________________________________________________________________________________________________________________________
Device Name: MFCD 1219
Indications for Use:
"The MFCD 1219 is intended to be used in displaying and viewing digital images for review by The Fire CD 1223 is meetage must not be used in primary image diagnosis in mammography.
Prescription Use XX_
(Part 21 CFR 801 Subpart D) ADD/OR
(21 CFR 801 Subpart C)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Siegerson
(Division Sign-Q Division of Reproductive. Abdor and Radiological D 510(k) Number
7
INDICATIONS FOR USE
.0(k) Number (if known): Ko52478_____________________________________________________________________________________________________________________________________________
Device Name: MFCD 1219 TS
Indications for Use:
"The MFCD 1219 TS is intended to be used in displaying and viewing digital images for review by The Fire D 1213 Your international with the used in primary image diagnosis in mammography.
Prescription Use _XX
(Part 21 CFR 801 Subpart D) AND/OR
(21 CFR 801 Subpart C)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Ingram
and Ra 510k) Nu