(10 days)
Not Found
No
The document describes a system for managing, viewing, and manipulating medical images, focusing on workflow and accessibility. There is no mention of AI, ML, or any algorithms that learn or make predictions based on data. The image processing mentioned appears to be standard manipulation and enhancement, not AI-driven analysis.
No
ViewStation is an image management system used to view, manipulate, and archive patient images. It is not an active therapy generator or therapeutic delivery system. The primary function of ViewStation is to manage image information in a therapy or treatment environment to increase department productivity, not to provide therapy itself.
No
The "Intended Use / Indications for Use" section explicitly states "ViewStation is not intended for use in diagnosis."
Yes
The description focuses entirely on software functionalities (importing, viewing, annotating, manipulating, enhancing, managing, and archiving digital images) and explicitly states it imports images from other products, implying it is a software application running on existing hardware. There is no mention of proprietary hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that "ViewStation is not intended for use in diagnosis." IVD devices are specifically designed to be used in vitro (outside the body) for the diagnosis of diseases or other conditions.
- Function: The primary function is to manage, view, annotate, and archive existing digital images acquired by other products. It facilitates the use of these images during therapy or treatment, not for making a diagnosis based on analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
The device appears to be a medical image management and viewing system used in a clinical setting for purposes other than diagnosis.
N/A
Intended Use / Indications for Use
ViewStation supports image and information flow among health care facility personnel. ViewStation can be used whenever digital images and associated data are the means for communicating information. ViewStation is not intended for use in diagnosis.
The intended use of ViewStation is to provide health care facility personnel with an effective means to utilize patient images during the course of therapy or treatment. ViewStation allows users to import, view, annotate, manipulate, enhance, manage, and archive patient images and associated information are stored in a database, providing users access to the information necessary to perform their functions.
Product codes
90 LLZ
Device Description
The primary function of ViewStation is to provide a means to more effectively manage image information in a therapy or treatment environment. ViewStation provides the ability to import, view, annotate, manipulate, enhance, and archive patient images during the course of therapy, treatment, and follow-up. ViewStation imports existing digital images acquired or generated by other products. ViewStation retains the original image, which was acquired or generated by a third party product. With these facts in mind, the goal of ViewStation is to make electronic patient image information more accessible throughout the department. IMPAC is providing a tool to increase department productivity since digital images, unlike films, do not have to be physically transferred from one station to another.
Mentions image processing
Yes
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
health care facility personnel / therapy or treatment environment
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
No additional or changed diagnostic or therapeutic claims arise as the result of the ViewStation product. Therefore, demonstration of clinical efficacy is not a required element of this Premarket Notification. Further, clinical performance data is not required for determination of substantial equivalence for this type and class of device.
IMPAC's Quality Engineering department has completed all product operation and hazard mitigation testing and has certified passing test results. Engineering was also performed to ensure that the algorithms and all other technical changes function exactly as intended. The testing demonstrated that the algorithms and all other functionality of ViewStation were successfully implemented.
Key Metrics
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
KO434/2
DEC 20 2004
Thursday, December 09, 2004
ViewStation, Image Management System Premarket Notification (510(k)) 510(K) Summary
Introduction
This document provides a summary of the safety and effectiveness information contained in the Viewstation Premarket Notification (510(k)). The Summary of Safety and Effectiveness contains no confidential or trade secret information and is intended for full public disclosure and distribution. For additional information, feel free to contact the submitter's Management Representative listed below.
Premarket Notification Information
-
- Previous Notification Information:
- Previous Premarket Notification # K011694, K 942346 a.
- Previous Submission Date 05/31/01, 05/16/94 b.
- 08/29/01, 05/15/95 Previous FDA Clearance Date c.
- ViewStation/Image RT d. Product Name
2. Product Information
| a. | Product Name | ViewStation |
|---|---|---|
| b. | Release Version Number | Version 8.2 |
| c. | Product Size | 4.9 MB |
Classification Information 3.
b.
C.
- Picture Archiving and Communications System a. Classification Name
Class II
Radiology
21 CFR 892.2050
- Common/Usual Name Image Management System
- Product Classification ದಿ.
- 90 LLZ Product Code b.
- CFR Reference
- Review Panel d.
4. Establishment Information
- Submitter IMPAC Medical Systems, Inc. e. f. Manufacturer (no sterilization) Submitter Type 2950347 Establishment Number g. Contact Thomas H. Faris, VP RA/QA h. 650-623-8807 i. Contact Phone Contact Email TFaris@impac.com j
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Predicate Device
ViewStation is substantially equivalent to the original ViewStation product, which is currently marketed by IMPAC Medical Systems, Inc., and was the subject of Premarket Notifications K011694 and K942346. The new ViewStation and previous ViewStation products are equivalent in intended use and safety and effectiveness.
ViewStation Indications for Use
ViewStation supports image and information flow among health care facility personnel. ViewStation can be used whenever digital images and associated data are the means for communicating information. ViewStation is not intended for use in diagnosis.
The intended use of ViewStation is to provide health care facility personnel with an effective means to utilize patient images during the course of therapy or treatment. ViewStation allows users to import, view, annotate, manipulate, enhance, manage, and archive patient images and associated information are stored in a database, providing users access to the information necessary to perform their functions.
Description of the Product
The primary function of ViewStation is to provide a means to more effectively manage image information in a therapy or treatment environment. ViewStation provides the ability to import, view, annotate, manipulate, enhance, and archive patient images during the course of therapy, treatment, and follow-up.
ViewStation imports existing digital images acquired or generated by other products. ViewStation retains the original image, which was acquired or generated by a third party product. With these facts in mind, the goal of ViewStation is to make electronic patient image information more accessible throughout the department. IMPAC is providing a tool to increase department productivity since digital images, unlike films, do not have to be physically transferred from one station to another.
Summary of the Product Change
The only modifications made to the product are the following evolutionary software changes:
- . Image viewing and image management feature improved annotation layer overlay, and image registration for calculation of relative reference position shifts.
- . Privacy and security functionality to support customer HIPAA compliance.
- User interface and product registration improvements. .
- . Other minor workflow enhancements that do not affect product safety or efficacy.
Clinical Demonstration of Efficacy
No additional or changed diagnostic or therapeutic claims arise as the result of the ViewStation product. Therefore, demonstration of clinical efficacy is not a required element of this Premarket Notification. Further, clinical performance data is not required for determination of substantial equivalence for this type and class of device.
Substantial Equivalence Comparison
ViewStation is substantially equivalent to the original ViewStation product, which is currently being marketed by IMPAC Medical Systems, Inc. This was the subject of Premarket Notifications K011694 and K942346.
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This Premarket Notification is a resubmission for ViewStation, triggered by enhancement of existing functionality. A I his realler incremental changes that are typical with routine software maintenance also accompany this change, but are too insignificant to merit discussion. The total sum of all feature enhancements does not affect the intended use of ViewStation. The technological characteristics remain principally the same. The evolutionary product changes does not raise any new questions of safety and effectiveness, nor do the changes require novel methods of verification or validation. The product change does not diminish the safety or effectiveness of ViewStation.
The modified ViewStation Image Management System has the following similarities to the previous product that received FDA 510(k) clearance:
- Identical indications for use; .
- . The same operating principles;
- Incorporation of the same basic product design; .
- Same materials a software only product; and .
- Sterility, biocompatibility, materials, mechanical safety, energy use, environmental . compatibility, and electrical safety all remain non-applicable issues.
The sum of the changes does not affect the basic functionality of ViewStation remains dedicated to providing healthcare personnel with a means to import, view, annotate, manage, and archive patient More simply, the changes do not affect the premise of the basic intended use of ViewStation: to provide images. healthcare facility personnel with an effective means to utilize patient images during the course of therapy or treatment. Once cleared by the FDA, IMPAC will continue to market and distribute ViewStation to be used in this manner.
In summary, the ViewStation Image Management System changes described in this submission are substantially equivalent to the predicate ViewStation device.
Device Safety
ViewStation is a medical device that is to be used in a treatment or therapy setting under the use of appropriately trained health care professionals who are responsible for ensuring the correct and accurate use of medical images.
The ViewStation System Hazard Analysis was performed to determine and evaluate all areas that represent potential safety or health hazards during ViewStation system operation. For all system hazards, effects, and mitigations have all been documented (SHA2102), reviewed, and implemented. This System Hazard Analysis is reviewed with every change and release of the product, including the above-mentioned changes. Validation and verification activities trace the hazard identification through evaluation, design, specification, implementation, and testing. The Design Review Team has reviewed the product change and System Hazard Analysis and has determined that the product change does not increase health or safety risk to patients, users, or other third parties.
Quality System
The fundamental goal of IMPAC's quality program is to provide value to customers and internal operations by producing better and safer products that are less expensive to build and maintain, simpler to use, and easier to support. IMPAC has implemented the IMPAC Ouality System to operate in a manner that has proven to be the most effective. Organizational experience and expertise is built into the management system to ensure that each process consistently meets defined specifications and continuously seeks improvement. All employees receive Quality System training and take pride in the value that they contribute to IMPAC products and to the final customer and their patients.
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ViewStation was developed according to the IMPAC Software Design Control Procedure (SDCP). This procedure governs the process by which system and software development are to be planned, dested, and released.
| DOC. ID | TITLE |
|---|---|
| ISO 9001:2000 | Quality Management Systems - Requirements |
| ISO 13485:2003 | Medical Devices - Quality Management Systems - System Requirements for |
| Regulatory Purposes | |
| ISO 14971:2000 | Medical Devices - Application of Risk Management to Medical Devices |
| EN 60601-1-4 :1996 | Medical Electrical Equipment - Part 1: General Requirements for Safety - 4. |
| Collateral Standard: Programmable Electrical Medical Systems | |
| ISO/IEC 9003 :2004 | Software Engineering - Guidelines for the Application of ISO 9001:2000 to |
| Computer Software | |
| 93/42/EEC | Medical Device Directive |
The IMPAC Quality System was developed in compliance with all of the following standards and regulations:
Verification and Validation Testing
A Traceability Matrix has been created, based upon the project plan, to ensure the completion of the specification, implementation, and testing of all requirements of the feature enhancement, including performance of full system hazard mitigation and basic operational testing. The System Test Plan for completing full application, integration, and system testing of ViewStation, while the Test Procedures capture the detailed testing parameters, results, and certification. A test certification statement certifies that the planned testing requirements were completed successfully. Design Reviews have been performed at the conclusion of each software design and development phase to review and validate the fulfillment of all of the phase requirements and deliverables. All of the above have been completed for ViewStation and representative documents are available for review.
Summary of Test Conclusions
IMPAC's Quality Engineering department has completed all product operation and hazard mitigation testing and has certified passing test results. Engineering was also performed to ensure that the algorithms and all other technical changes function exactly as intended. The testing demonstrated that the algorithms and all other functionality of ViewStation were successfully implemented.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2004
Mr. Thomas H. Faris Vice President RA/QA, Management Representative IMPAC Medical Systems, Inc. 100 West Evelyn Avenue MOUNTAIN VIEW CA 94041 Re: K043412 Trade/Device Name: ViewStation, Image Processing System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 9, 2004 Received: December 10, 2004
Dear Mr. Faris:
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 do not require approvisions 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.
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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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter witi anow you to oegh manceing of substantial equivalence of your device to a legally premarket nothreation. The I DA maing of batism 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 of your correst on our 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 notification" (21 CFR Also, please note the regulation on your responsibilities under the Act from the 807.97). You may obtain other general missistance at its toll-free number (800) Division of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmaldsmamain.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
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ViewStation Indications for Use Statement
510(k) Number (if known): _ic o4 3412
Device Name: ViewStation, Image Processing System
Indications for Use:
ViewStation supports image and information flow among health care facility personnel. ViewStation can be used whenever digital images and associated data are the means for communicating information. ViewStation is not intended for use in diagnosis.
The intended use of ViewStation is to provide health care facility personnel with an efficient and effective means to utilize patient images during the with an of therapy or treatment. ViewStation allows users to import, view, annotate, manipulate, enhance, manage, and archive patient images. The images and associated information are stored in a database, providing users access to the information necessary to perform their functions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
(Posted July 1, 1998)
Prescription Use
(Division Sign-Off Division of Reproductive, A and Radiological Dev 510(k) Number