(90 days)
Not Found
Not Found
No
The description focuses solely on data communication and format conversion according to the DICOM standard, with no mention of AI/ML algorithms for image analysis, interpretation, or decision support.
No.
The device is described as software for communication and data interchange of medical images, focusing on format conversion and transfer, without any mention of diagnosing, treating, or preventing disease.
No
The device is described as software for communication and data interchange between medical imaging devices, and for converting image formats. Its functions are related to data transfer and printing, not to interpreting images or diagnosing conditions.
Yes
The device is described solely as "software" and its function is to facilitate communication and data interchange of medical images, which is a software-based task. There is no mention of any accompanying hardware component that is part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is solely focused on communication and data interchange of medical images between different imaging devices. It does not mention any analysis of biological samples or providing information for diagnosis based on such analysis.
- Device Description: The description reinforces the role of the software as a connectivity package for converting and transferring image data. It doesn't describe any functionality related to analyzing patient samples or providing diagnostic information derived from them.
- Lack of IVD Characteristics: Typical characteristics of IVDs, such as analyzing blood, urine, tissue, or other biological samples, are completely absent from the description.
The device's function is purely related to the handling and transfer of medical images acquired from imaging modalities like NM, CT, MRI, and Ultrasound. This falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
DICOM 3.0 Software Version 2.0 is intended to provide communication and data interchange between multi-modality medical imaging devices, while maintaining the integrity of the image data.
Product codes
90 LMD
Device Description
DICOM 3.0 Software Version 2.0 is a connectivity package software developed according to the ACR-NEMA standard for Digital Imaging and Communication in Medicine (DICOM 3.0). This software converts medical images, such as NM, CT, MRI, or Ultrasound, that are in DICOM 3.0 specified format into Pegasys image format and vice-versa to enable data communication between ADAC Pegasys systems and other medical imaging devices.
Three major operations can be performed with DICOM 3.0 Software Version 2.0 - image data transfer between ADAC systems, data output to DICOM compatible printers, and transfer of image data between ADAC and non-ADAC systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
NM, CT, MRI, or Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Testing was conducted to demonstrate that the software functioned as per its specifications. Import and Export functions were comprehensively tested to ensure that image integrity was maintained. The Print functions were also tested. All tests passed with the actual results matching the expected results.
Summary of Performance Studies
Study Type: Software Functionality Testing
Sample Size: Not specified
Key Results: All tests passed with the actual results matching the expected results.
Key Metrics
Not Found
Predicate Device(s)
Cemax Vipstation, AVP PACSPRO 640
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA NOV 2 6 1997
I. General Information
| A. Submitted By: | ADAC Laboratories
540 Alder Drive
Milpitas, CA 95035
Tel: (408) 321-9100
Fax: (408) 321-9686 |
|-----------------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | Dennis Henkelman at address above |
| B. Device Trade Name: | DICOM 3.0 Software Version 2.0 |
| Common Name: | Gamma Camera System |
| Classification Name: | Digital Image Communication System |
| C. Predicate Device: | Cemax Vipstation
AVP PACSPRO 640 |
Device Description: D.
DICOM 3.0 Software Version 2.0 is a connectivity package software developed according to the ACR-NEMA standard for Digital Imaging and Communication in Medicine (DICOM 3.0). This software converts medical images, such as NM, CT, MRI, or Ultrasound, that are in DICOM 3.0 specified format into Pegasys image format and vice-versa to enable data communication between ADAC Pegasys systems and other medical imaging devices.
Three major operations can be performed with DICOM 3.0 Software Version 2.0 - image data transfer between ADAC systems, data output to DICOM compatible printers, and transfer of image data between ADAC and non-ADAC systems.
- E. Indications for Use:
DICOM 3.0 Software Version 2.0 is intended to provide communication and data interchange between multi-modality medical imaging devices, while maintaining the integrity of the image data.
1
Technological Comparison: F.
DICOM 3.0 Software Version 2.0 and the communication/data interchange portions of the predicate devices have the same indications for use. The operating principles of DICOM 3.0 Software Version 2.0 and the predicate devices are based on ACR-NEMA standard for Digital Imaging and Communication in Medicine (DICOM 3.0), as described in the device description. Communication media, such as, Local Area Network (LAN), Wide Area Network (WAN), and Internet are used to send or receive image data.
II. Testing
Testing was conducted to demonstrate that the software functioned as per its specifications. Import and Export functions were comprehensively tested to ensure that image integrity was maintained. The Print functions were also tested. All tests passed with the actual results matching the expected results.
2
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 1997
Dennis W. Henkelman Director, Regulatory Affairs and Quality Assurance ADAC Laboratories 540 Alder Drive Milpitas, CA 95035
K973239 DICOM 3.0 Software Version 2.0 Dated: August 22, 1997 Received: August 28, 1997 Regulatory class: Unclassified Procode: 90 LMD
Dear Mr. Henkelman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your 5100k) 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
W. Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K Y 1 32 3 7
DICOM 3.0 Software Version 2.0 Device Name:
ADAC Laboratories Sponsor Name:
Indications for Use
DICOM 3.0 Software Version 2.0 is intended to provide communication and data interchange between multi-modality medical imaging devices, while maintaining the integrity of the image data.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
David li. de yarm
Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
Over-The-Counter Use