(46 days)
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No
The summary describes a standard medical image viewing and manipulation workstation without mentioning any AI/ML capabilities.
No.
The device is a software application for rendering, visualizing, and manipulating medical images, primarily for diagnostic review and interpretation. It does not directly treat or cure any medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the software is intended to support "the image display needs of clinicians, diagnosticians and technologists" and that "Application capabilities enable primary diagnostic review, interpretation and distribution viewing for physician review." This indicates its role in diagnosis.
Yes
The device is described as a "software application" and its intended use is focused on the rendering, visualization, and manipulation of medical images, which are software-based functions. There is no mention of accompanying hardware components.
Based on the provided information, the Cerner ProVision Workstation is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the Cerner ProVision Workstation is for "rendering, visualization and manipulating of medical images." This involves processing images of the body, not analyzing biological samples.
- The description focuses on image display and manipulation. The capabilities listed are related to how medical images are presented and interacted with, which is characteristic of medical imaging software, not IVD devices.
Therefore, the Cerner ProVision Workstation falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cerner ProVision Workstation is a software application intended for the rendering. visualization and manipulating of medical images to support the image display needs of clinicians, diagnosticians and technologists.
Application capabilities enable primary diagnostic review, interpretation and distribution viewing for physician review.
The Cerner ProVision Workstation can be utilized in a standalone implementation, not interfaced or integrated to a Radiology Information System, or as component of a unified RIS/PACS solution.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA
Product codes
LLZ
Device Description
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Mentions image processing
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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
clinicians, diagnosticians and technologists.
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.)
Not Found
Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAR 2 7 2007
Ms. Shelley S. Looby, MT (ASCP) BB Director, Regulatory Affairs/Quality Assurance Cerner Corporation 2800 Rockcreek Parkway KANSAS CITY MO 64117-2551
Re: K070394
Trade/Device Name: Cerner ProVision™ Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 6, 2007 Received: February 9, 2007
Dear Ms. Looby:
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 max. 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.
Image /page/0/Picture/9 description: The image is a black and white circular logo. The logo commemorates the centennial of the FDA from 1906-2006. The letters FDA are in the center of the logo in a stylized font. Three stars are below the letters FDA.
Protecting and Promoting Public Health
1
Page 2 -
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 see 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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlvindustry/support/index.html.
Sincerely vours.
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K070394
Device Name: Cerner ProVisionTM Workstation
Indications for Use:
The Cerner ProVision Workstation is a software application intended for the rendering. visualization and manipulating of medical images to support the image display needs of clinicians, diagnosticians and technologists.
Application capabilities enable primary diagnostic review, interpretation and distribution viewing for physician review.
The Cerner ProVision Workstation can be utilized in a standalone implementation, not interfaced or integrated to a Radiology Information System, or as component of a unified RIS/PACS solution.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA
Prescription Use
Prescription Use (Part 21 CFR 801 Subpar
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
David A. Ingram
(Division Sign-Off Division of Repr. J Radiological I 510(k) Number