(70 days)
No
The description focuses on standard DICOM archival and distribution functionalities using established technologies like SQL Server and Windows NT. There is no mention of AI, ML, or any image processing that would typically involve such technologies. The document explicitly states "no image processing is done by this product".
No.
This device is a software product that provides centralized management and storage of radiographic studies, and facilitates distribution of these studies for viewing by medical professionals. It does not provide any therapeutic function.
No
Explanation: The device description explicitly states functionalities like archival, storage, and distribution of radiographic studies. It also clearly mentions "no image viewing is provided by this product" and that it primarily manages and stores images. The DIS is described as providing a means for medical professionals to display data, and it mentions that if lossy compression were used (which it generally doesn't for full resolution images), it would be "for secondary viewing only and not for diagnostic interpretation." These statements strongly indicate that the device's purpose is not for primary diagnosis.
Yes
The document explicitly states "This software-only product is fully DICOM-3.0 compliant..." and "This product consists only of software and executes in a Windows© NT© environment on Intel© platforms." It also clarifies that the reliability and disaster recovery are dependent on the hardware and installation, further indicating the device itself is solely the software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this product manages and stores radiographic studies (medical images). It does not process or analyze biological samples like blood, urine, or tissue.
- The device description explicitly states "no image processing is done by this product". While some IVDs might involve image analysis (e.g., analyzing images of cells), this device's primary function is storage and management of existing images.
- The intended users are licensed medical professionals for viewing and managing radiographic images. This aligns with the use of a PACS (Picture Archiving and Communication System), which is the proposed FDA designation mentioned.
In summary, this device is a medical image management and storage system, not a diagnostic tool that analyzes biological specimens.
N/A
Intended Use / Indications for Use
The DICOM Archival Server (DAS)/DICOM IntraNET Service (DIS), software product, provides for the centralized management and storage of radiographic studies, replacing or augmenting the historical film-based processes.
Product codes (comma separated list FDA assigned to the subject device)
90 LMB
Device Description
The DICOM Archival Server (DAS) software product provides for the centralized management and storage of radiographic studies, replacing or augmenting the historical film-based processes. The operating system utilizes Microsoft @ Windows NT @ Release 4.0 and later. This environment provides for all communication (i.e. TCP/IP), file storage (e.g. NTFS), security management, and display management processes. It also insulates the DAS from detail hardware management processes, allowing customers to make whatever choices in these areas best serve them. This environment supports a variety of back-up/restore processes which may be used at the customer's discretion. The Microsoft© SQL Server product is used as the primary management component for the archive contents and for responding to requests. whether they be in the form of SQL Server direct requests or via the DICOM Query/Retrieve process. This software-only product is fully DICOM-3.0 compliant for the following DICOM Service Classes: Verification (SCP), Storage (SCP and SCU), Query/Retrieve (SCP), Print (SCU), Patient Management (SCU), Study Management (SCU), Results Management (SCU). This product consists only of software and executes in a Windows© NT© environment on Intel© platforms. This product, when combined with appropriate server platform hardware and operating system, falls into the FDA proposed designation of a PACS system as Class II (Special Controls). The following attributes are noted: this product accepts, stores and transfers images; no image processing is done by this product; no compressed images are accepted for storage by this product; this product will supply compressed images as requested by client products, at the level of compression requested by those clients; no image viewing is provided by this product; the reliability of the product is dependent upon the hardware on which the software is installed, and is determined by the installation; disaster recovery attributes of an installation are dependent upon installation-determined policies, and are totally under the control of the installation. The DAS product contains the following advanced features to facilitate rapid movement of images to desired targets within a PACS system: automatic image forwarding and automatic image printing. Automatic image forwarding enables a policy-managed forwarding process wherein each image received by the DAS will automatically be forwarded to one or more target workstations based upon the following image contents: modality station name, body part, referring physician, and modality type. Automatic image printing is an extension of the automatic forwarding process wherein the forwarding target is a DICOM Print Service Class Provider. The DICOM IntraNET Service (DIS) software product provides for centralized distribution of stored radiographic studies. DIS is an integrated client-server software system designed to allow secured access to radiographic images by licensed medical professionals. The software's server and client ends rely on off-the-shelf Windows NT software with compatible Intel hardware. The client end accesses images through a WEB Browser similar to Microsoft's Internet Explorer through a Query/Retrieve process. The DIS system becomes an extended Viewer attached to a secured internal network or an extended secured Intranet using TCP/IP communications protocol. Full resolution, lossless images are always available to the Client Browser.
Mentions image processing
No image processing is done by this product
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed medical professionals / centralized management and storage
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K960326, K960946, K960981, K961160, K970064
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(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
3 1998
510(k) Summary
1. Company Identification
Parameter Developments, Inc. 15711 Highway 101 South Harbor, Oregon 97415 Tel. (541) 412-0321 Fax (541) 412-0277
2. Official Correspondent
Gary J. Allsebrook Regulatory Affairs
3. Date of Submission
January 21, 1998
4. Device Name
| Classification Name: | Digital Image Storage System/
Teleradiology System |
|----------------------|-------------------------------------------------------------------------------------|
| Common/Usual Name: | Picture Archiving and Communications System |
| Proprietary Name: | Parameter Developments, DICOM Archival Server
(DAS)/DICOM IntraNET Service (DIS) |
5. Substantial Equivalence
Fuji, FCR DMS Optical Disk Image Filing System, OD-F614, K960326 Lockheed. ECHONET, K960946 Kodak, Kodak Digital Science (KDS) Medical Image and Info, K960981 Base Ten Systems, UPACS Version 1.7, K961160 Autocyt Group, Inc. AMICAS Web/Intranet Server, K970064
6. Device Description and Intended Use
The DICOM Archival Server (DAS) software product provides for the centralized management and storage of radiographic studies, replacing or augmenting the historical filmbased processes.
The operating system utilizes Microsoft @ Windows NT @ Release 4.0 and later. This environment provides for all communication (i.e. TCP/IP), file storage (e.g. NTFS), security management, and display management processes. It also insulates the DAS from detail hardware management processes, allowing customers to make whatever choices in these areas best serve them.
This environment supports a variety of back-up/restore processes which may be used at the customer's discretion.
1
The Microsoft© SQL Server product is used as the primary management component for the archive contents and for responding to requests. whether they be in the form of SQL Server direct requests or via the DICOM Query/Retrieve process.
This software-only product is fully DICOM-3.0 compliant for the following DICOM Service Classes:
| Service Class | Service Type |
|---|---|
| Verification | SCP |
| Storage | SCP and SCU |
| Query/Retrieve | SCP |
| SCU | |
| Patient Management | SCU |
| Study Management | SCU |
| Results Management | SCU |
This product consists only of software and executes in a Windows© NT© environment on Intel© platforms. This product, when combined with appropriate server platform hardware and operating system, falls into the FDA proposed designation of a PACS system as Class II (Special Controls). The following attributes are noted:
- . this product accepts, stores and transfers images;
- . no image processing is done by this product;
- no compressed images are accepted for storage by this product; .
- this product will supply compressed images as requested by client products, at . the level of compression requested by those clients;
- . no image viewing is provided by this product;
- the reliability of the product is dependent upon the hardware on which the ● software is installed, and is determined by the installation;
- . disaster recovery attributes of an installation are dependent upon installationdetermined policies, and are totally under the control of the installation.
The DAS product contains the following advanced features to facilitate rapid movement of images to desired targets within a PACS system:
- automatic image forwarding .
- automatic image printing .
Automatic image forwarding enables a policy-managed forwarding process wherein each image received by the DAS will automatically be forwarded to one or more target workstations based upon the following image contents:
- . modality station name,
- bodv part. .
- . referring physician, and
- . modality type.
Automatic image printing is an extension of the automatic forwarding process wherein the forwarding target is a DICOM Print Service Class Provider.
The DICOM IntraNET Service (DIS) software product provides for centralized distribution of stored radiographic studies. DIS is an integrated client-server software system designed to allow secured access to radiographic images by licensed medical professionals. The software's server and client ends rely on off-the-shelf Windows NT software with compatible
2
Intel hardware. The client end accesses images through a WEB Browser similar to Microsoft's Internet Explorer through a Query/Retrieve process.
The DIS system becomes an extended Viewer attached to a secured internal network or an extended secured Intranet using TCP/IP communications protocol. Full resolution, lossless images are always available to the Client Browser. If lossy compression where used, similar to our equivalent products listed in item 10; Kodak, Base-Ten, or Autocyt, we would recommend that they be used for secondary viewing only and not for diagnostic interpretation.
This DIS software is intended to provide the means for medical professionals to display data generated by medical scanning devices on a personal computer or workstation. Competent healthcare professionals would reasonably be expected to exercise judgment in use of this information.
7. Hazard Analysis
Hazard analysis on this product has been performed throughout the definition, design, coding and testing phases of product development and implementation. This process has emphasized:
- . identification of potential hazards, their causes, and their effects;
- development of methodologies to control the occurrence of hazards and to . constrain their effects; and
- determine any effect on patient safety and system effectiveness. .
The potential hazards associated with this software product are no different than those of other PACS storage facilities. These are primarily related to failure of computer system components, and may be variously obviated by decisions taken by the customers of this product. None of these failures are expected to materially contribute to patient death or iniurv.
It is our conclusion that there is no hardware or software component, operating in a properly configured environment, whose failure or latent design defect would be expected to result in death or injury of a patient. Thus the "Level of Concern" is "Minor".
Additional discussion is available in the following sections.
8. Safety Concerns
All hardware associated with a PACS system based upon this product is standard, off-theshelf hardware used for server applications. This hardware has been approved by UL and CSA. The hardware will comply with part 15 of the FCC rules, as well as the DHHS Radiation Performance Standards (21 CFR Subchapter J) as appropriate.
It is important to note that the institution has the option of installing redundancy in its networks to obviate failure problems and increase reliability. Such redundant components are managed by the hardware and software environment, not by the DAS/DIS.
9. Data Compression
Only uncompressed images are accepted for storage in the DAS. Once received, the image files are stored via the standard disk processes supplied by Windows NT, which can include a lossless compression. Lossy compression techniques are never used in storing images in the DAS. Once an image file has been stored by the DAS, it will provide for either uncompressed,
3
lossiessly compressed, or lossily compressed image transmission to clients. The form of compression available is the full spectrum of compression algorithms currently supported by DICOM, as well as Wavelet compression fireuot a specialized transfer syntax. Compressed images are only provided to a chient which has explicitly requested a compressed transmission, and then only in the format which was requested by the client. The standard DICOM header of the file sent to a client identifies any use of compression. Any client requesting use of compression techniques must images, when displayed, with an indication of any use of lossy compression.
If is our recommendation that losey compression not be used by clients which support diagnostic processes.
10. Substantial Equivalence
The following products provide functions which are substantially equivatent to this product.
| Product Name | PDI
DAS/
DIS | FUJI
DMS | Lockheed
EchoNet
Server | Kodak
KDS-
Mill. | Base-Ten
uPACS
1.7 | Autocyl
AMICAS |
|------------------------|--------------------|-------------|-------------------------------|------------------------|--------------------------|-------------------|
| 510(k) | K9060326 | K960326 | K960946 | K960981 | K961160 | K970064 |
| Hardware | Intel | ? | Intel | Sun | Intel | Intel |
| Operating System | Win NT | ? | UNIX | UNIX | Win 95 | ? |
| Ethernet | yes | yes | yes | yes | yes | yes |
| FDDI | yes | no | yes | yes | no | ? |
| ATM | yes | no | yes | yes | no | no |
| Magnetic Disk | yes | yes | yes | yes | yes | yes |
| Optical Disk | yes | yes | yes | no | yes | ? |
| CD-ROM | yes | no | ? | yes | yes | yes |
| Magnetic Tape | yes | no | yes | ? | ? | no |
| Magnetic Disk | 96GB | ? | ? | 100GB | ? | ? |
| Optical Disk/CD-ROM | 2.5TB | 1.0TB | ? | 116GB | ? | ? |
| Magnetic Tape | Note 1 | no | ? | N/A | N/A | N/A |
| Image Viewing | yes | no | yes | no | yes | yes |
| Image Manipulation | yes | no | yes | no | yes | yes |
| DICOM-3 Storage | yes | no | ? | yes | no | yes |
| DICOM-3 Query/Retrieve | yes | no | ? | yes | no | ? |
| HIS/RIS Interface | yes | no | no | no | no | no |
| TCP/IP | yes | yes | yes | yes | yes | yes |
| Uncompressed | yes | no | yes | yes | yes | yes |
| Lossless | yes | yes | yes | ? | ? | yes |
| Lossy | no | no | yes | ? | ? | no |
| Uncompressed | yes | no | no | yes | yes | yes |
| Lossless | yes | yes | yes | ? | ? | yes |
| Lossy | yes | no | ? | ? | ? | ? |
Note 1: offline storage of tape is not limited.
ప్ర
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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1998 APR
Parameter Developments, Inc. c/o Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578
Re:
K980243 DICOM Archival Server (DAS)/DICOM IntraNet Service (DIS) Dated: January 21, 1998 Received: January 23, 1998 Regulatory class: Unclassified 21 CFR 892.2010/Procode: 90 LMB
Dear Mr. Allsebrook:
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 province 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). 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 (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 requirements, 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitio 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/odrf/dsmaldsmamain.html".
Sincerely yours,
Sincerely yours,
William Yu, Ph.D.
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
5
510(k) Number (if known):
Device Name: DICOM Archival Server (DAS)/DICOM IntraNET Service (DIS)
Indications for Use: The DICOM Archival Server (DAS)/DICOM IntraNET Service (DIS), software product, provides for the centralized management and storage of radiographic studies, replacing or augmenting the historical film-based processes.
The operating environment is provided by Microsoft's © NT ©operating system. Release 4 and later only. This environment provides for all communication (i.e. TCP/IP), file storage (e.g. NTFS), security management and display management processes. It also insulates the DAS/DIS from detail hardware management processes, allowing customers to make whatever choices in these areas that best serve them.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 901.109)
OR
Over-the-Counter Use
David L. Seymon
(Optional Format 1-2-96)
ymm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic
510(k) Number K980243