(10 days)
Not Found
No
The summary describes a standard PACS system with image processing capabilities, but there is no mention of AI, ML, or related terms, nor any description of training or test data sets typically associated with AI/ML devices.
No.
The device is described as a Picture Archival and Communications System (PACS) for diagnostic images, primarily focusing on storage, retrieval, display, and manipulation of these images, rather than directly treating a medical condition.
No
Explanation: The device is a Picture Archival and Communications System (PACS) that stores and displays images from diagnostic devices. While it handles diagnostic images, it does not perform the diagnostic imaging itself or interpret the images to provide a diagnosis. Its function is to manage and process existing diagnostic images, not generate new diagnostic information.
No
The device description explicitly states that KinetDx includes a dedicated DICOM server and one or more workstations, which are hardware components.
Based on the provided information, the KinetDx 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.
- KinetDx Function: The KinetDx system is a PACS (Picture Archival and Communications System). Its primary function is to manage, store, display, and process medical images obtained from various imaging modalities (ultrasound, CT, MRI, X-ray angiography).
- No Sample Analysis: The description of the KinetDx does not mention any analysis of biological samples. It deals solely with medical images.
Therefore, the KinetDx falls under the category of medical imaging devices and systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the KinetDx, is for the acceptance, transfer, display, storage, and digital processing of diagnostic ultrasound, CT, MRI, and X-ray angiography images, including manipulation and quantification of the images.
Product codes
90 LLZ
Device Description
KinetDx is a picture archival and communications system (PACS) that includes a dedicated DICOM server used for image and data storage, retrieval, and archiving. The server accepts images and data from DICOM acquisition devices attached to it by way of a network. The system also includes one or more workstations networked with the server, which are used for clinical review of images and data. Workstations also allow editing of patient demographic and clinical data, image manipulation, and preparation of clinician's reports.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
diagnostic ultrasound, CT, MRI, and X-ray angiography
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
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)
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
K023772
510(k) Summary of Safety and Effectiveness
Acuson Corporation's KinetDx - Medical Image Management Device
Acuson Corporation has not disclosed its intent to market this device modification and requests this notification be held CONFIDENTIAL by FDA, and not be released to any Freedom of Information request or addressed with any outside parties.
| Sponsor: | Siemens Medical Solutions,
Acuson Ultrasound Division
1230 Shorebird Way
Mountain View, CA 94043 |
|-----------------|-----------------------------------------------------------------------------------------------------------|
| Contact Person: | Bob Leiker
Senior Regulatory Affairs Specialist
Telephone: (650) 694-5080
Fax: (650) 961-6168 |
Submission Date: October 31, 2002
Device Name: KinetDx
Common or Usual Name: Picture Archival and Communications System
Classification:
Picture Archival and Communications System (LLZ) class II (21CFR §892.2050)
Predicate Device:
EchoLink, K980060 cleared on February 25, 1998 ALI UltraPacs, K925965 cleared on June 14, 1993 ALI DataComPacs Module, K963610, cleared on November 27, 1996
Device Description:
KinetDx is a picture archival and communications system (PACS) that includes a dedicated DICOM server used for image and data storage, retrieval, and archiving. The server accepts images and data from DICOM acquisition devices attached to it by way of a network. The system also includes one or more workstations networked with the server, which are used for clinical review of images and data. Workstations also allow editing of patient demographic and clinical data, image manipulation, and preparation of clinician's reports.
Intended Use:
The intended use of the KinetD, is for the acceptance, transfer, display, storage, and digital processing of diagnostic ultrasound, CT, MRI, and X-ray angiography images, including manipulation and quantification of the images.
1
Technological Characteristics and Substantial Equivalence:
Similar to the predicate devices, the computer hardware components used for the KinetDx server and review stations are standard computer hardware procured from qualified vendors, with the exception of an optional proprietary card available for review stations. This optional card, the KinetDx Dynamic Array Processor (DAP) card, provides faster decompression and display of image data than can be provided using regular system memory. The KinetDx server and review stations use proprietary software to accomplish their functions. Servers and review stations use the Windows2000 operating system.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Rockville MD 208
2.2. 2007
Acuson Corporation % Mr. Mark Job : 510(K) Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K023772
Trade/Device Name: KinetDx Picture Archiving and Communications System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: November 8, 2002 Received: November 12, 2002
Dear Mr. Job:
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.
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Page 2
This letter will allow you to begin marketing your device as described in your 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 this letter:
| 8xx.1xxx | (301) 594-459 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-461 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-461 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-465 |
| Other | (301) 594-469 |
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 Part 807.97). 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,
Henry C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KUL 3772
Incintended use of the KinetDy Indications For Use
The intended use of the KinetDy, is for the acceptance, display, storage, and digital processing of diagnostic ultrasound, CT, MRI, and X-ray angiography images, including manipulation and quantification of the images.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Legum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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