(63 days)
Not Found
None
No
The summary describes a standard PACS system for image management and display, with no mention of AI, ML, or related concepts like image analysis, detection, or quantification that would typically involve such technologies.
No.
The device's intended use is for the manipulation, management, and display of medical images, which are diagnostic functions, not therapeutic.
No
The description explicitly states its purpose is for "manipulation, management, and display of medical images," and does not mention any function related to diagnosing diseases or conditions.
Unknown
The summary describes the function of a PACS system, which is typically software, but it doesn't explicitly state that the device is only software and doesn't include any associated hardware components.
Based on the provided information, the MDV-PACS device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the MDV-PACS device is for the manipulation, management, and display of medical images. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The function is image processing and management. The core function is handling and displaying images from various modalities, not performing tests on biological specimens to diagnose or monitor a condition.
Therefore, the MDV-PACS device falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an IVD.
N/A
Intended Use / Indications for Use
The MDV-PACS device is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards.
Product codes
90 LLZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
images from different modalities
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this software system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
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)
Not Found
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/1 description: The image shows a circular logo with text around the perimeter and a stylized eagle in the center. The text around the perimeter reads "DEPARTMENT OF HEALTH & HUMAN SERVICES". The eagle is depicted with three curved lines representing its body and wings, giving it a modern and abstract appearance.
AUG 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DVNET International Technology Co., Ltd. % Dr. Jen Ke-Min Official Correspondent ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chi City, (Taiwan) 300 CHINA
Re: K031816
Trade/Device Name: DVNET MDV-PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: May 30, 2003
Received: June 12, 2003
Dear Dr. Ke-Min:
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 (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); 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.
1
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 Part 801), please contact the Office of Compliance at one of the 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.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
Page 2
2
Ko3 1816
2.2 FDA Indication for Use Form :
DVNET INTERNATIONAL TECHNOLOGY CO., LTD. Applicant : ___
510(k) Number :
Device Name : DVNET MDV-PACS
Indications for Use :
● The MDV-PACS device is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards.
Typical users of this software system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter (Optional Format 1-2-96)
David A. Segner
(Division Sign-Off Division of Reproductive, Abdomin and Radiological Devices 510(k) Number