(59 days)
No
The summary describes standard image processing and visualization techniques (MPR, Digital Subtraction, 3D) and does not mention any AI or ML capabilities.
No
The device is used for the acquisition, display, digital processing, review, transfer, storage, archiving, and printing of medical images and patient information for diagnostic purposes, not for treating diseases or conditions.
Yes
The device is explicitly stated to "aid in diagnosis" by physicians, indicating its role in the diagnostic process. Furthermore, one of the configurations is described as a "general purpose diagnostic workstation."
No
The device description explicitly mentions "Workstation configurations" and different models (DS3000, Cardio3000, OT3000, CS5000, QC3000), which are hardware components. While the MPR, Digital Subtraction, and 3D features are software options, the core device is a workstation, which is a hardware system.
Based on the provided text, this 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.
- Device Function: The description clearly states the device is a "medical image management device" used for "acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images." It processes and displays images, not biological samples.
- Intended Use: The intended use is to "aid in diagnosis" by providing access to and manipulating medical images. This is distinct from performing a diagnostic test on a biological sample.
The device is a medical imaging workstation, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
IMPAX® Workstations with MPR, Digital Subtraction and 3D options are intended for use in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information.
They are indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.
MPR and 3D functions allow the user to view 3D image data from perspectives different from that in which it was acquired. Digital subtraction allows a user viewing time series studies to remove densities not enhanced by a contrast medium, highlighting vascular structures.
Product codes
90 LLZ
Device Description
The predicate devices and IMPAX® Workstations with MPR, Digital Subtraction and 3D options are medical image management devices.
Workstation configurations include a general purpose diagnostic workstation (DS3000) and analogous versions for cardiologists (Cardio3000) and orthopedists (OT3000). A review workstation (CS5000) is available for use by persons other than the interpreting physicians; and a quality control workstation (QC3000) provides administrative functions and the ability to view and correct improper operator entries.
The multi-planar reconstruction, digital subtraction and 3D features described in this notification will be offered as options, either separately or combined on multiple workstation configurations.
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
physician, medical 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
IMPAX Workstations with MPR, Digital Subtraction and 3D options are subject to testing according to established procedures by both Agfa and the software developer. No product will be released for distribution or sale until all required tests and validation activities have been successfully combleted.
Tests are conducted according to documented test plans. Records of test results are maintained.
The following types of tests are conducted:
Unit tests - Tests of a single component or module, usually conducted by or under the direction of development personnel.
System tests - Tests of multiple components or modules, up to and including the entire system. System tests are conducted by persons independent of the development personnel.
Integration tests – Tests by Agfa of system performance under simulated use conditions.
Field tests - Tests of a complete system in a user setting, but under the direct control of Agfa.
Beta tests - Tests of a system in a user setting, but without the immediate or direct control of Agfa.
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
| PMN | |
|---|---|
| K022292 | |
| NOT DEFINED | |
| NOT DEFINED | |
| 510K Summary | |
| 12-SEP-2002 | |
| 001 | |
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SEP 1 2 2002
510(k) Summary
IMPAX® Workstations with MPR, Digital Subtraction and 3D options
Common/Classifications Name: Picture Archiving and Communications System, 21 CFR 892.2050
Agfa Corporation 10 South Academy Street Greenville SC 29602-9048 Contact: Jeff Jedlicka, Prepared July 10, 2002
Legally Marketed Predicate Devices A.
The legally marketed predicate devices are the Philips EasyVision workstations with Endo-3D option (cleared on January 8, 1998 as K973983) and Quantitative Analysis option (cleared on January 30, 1998 as K971965).
Device Description в.
The predicate devices and IMPAX® Workstations with MPR, Digital Subtraction and 3D options are medical image management devices.
Workstation configurations include a general purpose diagnostic workstation (DS3000) and analogous versions for cardiologists (Cardio3000) and orthopedists (OT3000). A review workstation (CS5000) is available for use by persons other than the interpreting physicians; and a quality control workstation (QC3000) provides administrative functions and the ability to view and correct improper operator entries.
The multi-planar reconstruction, digital subtraction and 3D features described in this notification will be offered as options, either separately or combined on multiple workstation configurations.
C. Intended Use
IMPAX® Workstations with MPR, Digital Subtraction and 3D options are intended for use in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information.
They are indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.
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MPR and 3D functions allow the user to view 3D image data from perspectives different from that in which it was acquired. Digital subtraction allows a user viewing time series studies to remove densities not enhanced by a contrast medium, highlighting vascular structures.
Substantial Equivalence Summary D.
Impax® Workstations with MPR, Digital Subtraction and 3D options have the same intended use as the predicate devices. The differences in indications statements do not alter the intended diagnostic effect. Both the IMPAX® Workstations with MPR, Digital Subtraction and 3D, and the predicate devices are intended for use by the physician to assist in diagnosis.
The image manipulation tools are comparable. Each tool gives the user an ability to view image data from a perspective different from the one in which it was acquired.
Both IMPAX® workstations and Philips EasyVision workstation (Endo-3D, K973983) allow the user to choose optional planes from which to view three dimensional image data, and to create and view three dimensional representations.
Both IMPAX® workstations and Philips EasyVision workstation (Quantitative Analysis, K971965) allow the user viewing time series studies to remove image densities not enhanced by a contrast medium.
E. Technological Characteristics
The workstations have the same technological characteristics. All are of similar design and constructed of similar materials.
All products operate on commercially available computer systems.
All comply with the DICOM standard for communications with other imaging system components.
ட் Testing
IMPAX Workstations with MPR, Digital Subtraction and 3D options are subject to testing according to established procedures by both Agfa and the software developer. No product will be released for distribution or sale until all required tests and validation activities have been successfully combleted.
Tests are conducted according to documented test plans. Records of test results are maintained.
The following types of tests are conducted:
Unit tests - Tests of a single component or module, usually conducted by or
3
under the direction of development personnel.
System tests - Tests of multiple components or modules, up to and including the entire system. System tests are conducted by persons independent of the development personnel.
Integration tests – Tests by Agfa of system performance under simulated use conditions.
Field tests - Tests of a complete system in a user setting, but under the direct control of Agfa.
Beta tests - Tests of a system in a user setting, but without the immediate or direct control of Agfa.
G. Conclusions
This premarket notification has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
ﺑﺘﺼﺪ
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is an abstract image of an eagle's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2002
Re: K022292
Agfa Corporation HealthCare Division % Mr. David D. Ledwig Principal Consultant Practical Compliance, LLC P.O. Box 1927 BREVARD NC 28712
Trade/Device Name: IMPAX® workstations with MPR, Digital Subtraction and 3D Options Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: July 10, 2002 Received: July 15, 2002
Dear Mr. Ledwig:
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.
5
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) 594-4591 |
|---|---|
| 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" (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,
Nancy C. Brigdon
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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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name: IMPAX® Workstations with MPR, Digital Subtraction and 3D options
Indications For Use:
IMPAX® Workstations with MPR, Digital Subtraction and 3D options are intended for use in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information.
They are indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.
MPR and 3D functions allow the user to view 3D image data from perspectives different from that in which it was acquired. Digital subtraction allows a user viewing time series studies to remove densities not enhanced by a contrast medium, highlighting vascular structures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE (F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K022292 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
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