(28 days)
Not Found
No
The document describes a medical image viewing and processing workstation with various features and add-ons, but there is no mention of AI or ML technology being used for image analysis, diagnosis assistance beyond basic tools, or any other function. The focus is on image display, manipulation, and workflow management.
No
The device is described as a software product for the visualization and processing of medical images, intended for diagnostic review and medical image management, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states that the device is for "manipulation and displaying of medical images". Furthermore, the "Device Description" table explicitly lists "IDS5/dx.net" and "IDS7/dx" as "diagnostics workstation[s]" that "contains tools for assisting the radiologist in making a diagnosis," and IDS5/mx.net as a "dedicated workstation for mammography" that has "all functionality as an IDS5/dx.net". The document also specifies that "For primary diagnosis, post process DICOM 'for presentation' images must be used."
No
While the device is described as "mainly a software product" and runs on PCs, it explicitly states it is used as a client together with a "Sectra provided server (Class I Exempt)". This indicates a hardware component provided by the manufacturer, preventing it from being a software-only medical device.
Based on the provided information, the Sectra Workstation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is defined as a reagent, instrument, or system intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Sectra Workstation's Function: The Sectra Workstation is primarily a software product used for the manipulation and displaying of medical images acquired from various imaging modalities (like mammography, etc.). It processes and visualizes these images for diagnostic review by trained professionals.
- No Specimen Examination: The device does not involve the collection, preparation, or examination of biological specimens from the human body. Its input is digital image data, not biological samples.
Therefore, the Sectra Workstation falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS) workstation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sectra Workstation is intended for the manipulation and displaying of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc.; and teleconferencing.
Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
For primary diagnosis, post process DICOM "for presentation" images must be used.
Product codes
LLZ
Device Description
The Sectra Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The Sectra Workstation is used as a client together with a Sectra provided server (Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.
The Sectra Workstation is a family of devices, including several workstations or types of workstations.
Workstation type: IDS5/dx.net
Description: A diagnostics workstation. It contains tools for assisting the radiologist in making a diagnosis.
Workstation type: IDS5/mx.net
Description: The dedicated workstation for mammography. It has all functionality as an IDS5/dx.net but with additional mammography features. Note! Reading of mammographic images shall only be conducted with IDS5/mx.net.
Workstation type: IDS5/qa.net
Description: The quality assurance workstation in the Sectra Workstation family. Mainly used by the technologists to prepare the images for the reviewing radiologist.
Workstation type: IDS5/mqa.net
Description: New! The quality assurance workstation to be used by a mammography technician to prepare images for the reviewing radiologist.
Workstation type: IDS5/cl.net
Description: Used by the clinicians within the hospital to view the radiology images and to read the radiology report.
Workstation type: IDS5/web
Description: A slim version of the Sectra Workstation that can be used by remote clinics to view images and radiology reports.
Workstation type: IDS5/home
Description: An at-home workstation of the diagnostics workstation that can be used by the radiologist over a low bandwidth connection.
Workstation type: IDS5/doc
Description: A limited workstation that is used to scan radiology requests.
Workstation type: IDS5/send
Description: A teleradiology workstation that is used to send examinations to teleradiology destinations.
Workstation type: IDS7/dx
Description: New! A diagnostics workstation, based on the new software architecture. It contains tools for assisting the radiologist in making a diagnosis.
To handle specific user needs it is also possible to activate Sectra developed add-ons for the Sectra Workstation. The add-on is thus an additional feature set that can be used on the Sectra Workstation. Some add-ons were add-ons on Sectra Workstation IDS5 but are included as ordinary features for IDS7. Examples:
Add-on: Volume rendering (3D)
Sectra Workstation IDS5: X
Sectra Workstation IDS7: X
Add-on: Clinical Application Interface slots (2 additional)
Sectra Workstation IDS5: X
Sectra Workstation IDS7:
Add-on: Dual monitor support
Sectra Workstation IDS5: X
Sectra Workstation IDS7: Included in IDS7 by default.
Add-on: Multiframe support
Sectra Workstation IDS5: X
Sectra Workstation IDS7: Included in IDS7 by default.
Add-on: Image cache
Sectra Workstation IDS5: X
Sectra Workstation IDS7: Included in IDS7 by default.
Add-on: DICOM print support
Sectra Workstation IDS5: X
Sectra Workstation IDS7:
Add-on: Image scanner support
Sectra Workstation IDS5: X
Sectra Workstation IDS7:
Add-on: Basic document scanner support
Sectra Workstation IDS5: X
Sectra Workstation IDS7:
Add-on: Demonstration scheduling
Sectra Workstation IDS5: X
Sectra Workstation IDS7:
Add-on: Nuclear medicine image controls
Sectra Workstation IDS5: X
Sectra Workstation IDS7:
Add-on: Patient CD
Sectra Workstation IDS5: X
Sectra Workstation IDS7:
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
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
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)
The subject device is developed according to ISO 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
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
510(k) Summary of Safety & Effectiveness
(as required by 21 CFR 807.92c)
Date Prepared:
October 4, 2006
Submitter's Information:
Sectra Imtec AB Teknikringen 20 SE-583 30 Linköping Sweden Phone: +1 46 13 23 52 00 Fax: +1 46 13 21 21 85
Trade Name, Common Name, Classification:
| Trade Name: | Sectra Workstation |
|---|---|
| Software version: | 11.1 |
| Common Name: | Picture Archiving and Communications System |
| Classification Name: | Image Processing System (LLZ) (21 CFR § 892.2050) |
Predicate Device:
| Applicant: | Sectra Imtec AB |
|---|---|
| 510(k) Number: | K051315 |
| Device: | Sectra IDS5 Workstation |
Device Description:
The Sectra Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The Sectra Workstation is used as a client together with a Sectra provided server (Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.
The Sectra Workstation is a family of devices, including several workstations or types of workstations.
| Workstation
| type | Description |
|---|---|
| IDS5/dx.net | A diagnostics workstation. It contains tools for assisting the radiologist |
| in making a diagnosis. | |
| IDS5/mx.net | The dedicated workstation for mammography. It has all functionality |
| as an IDS5/dx.net but with additional mammography features. | |
| Note! Reading of mammographic images shall only be | |
| conducted with IDS5/mx.net. | |
| IDS5/qa.net | The quality assurance workstation in the Sectra Workstation family. |
| Mainly used by the technologists to prepare the images for the | |
| reviewing radiologist. | |
| IDS5/mqa.net | New! The quality assurance workstation to be used by a |
| mammography technician to prepare images for the reviewing | |
| radiologist. |
NOV - 7 2006
1
| Workstation type | Description |
|---|---|
| IDS5/cl.net | Used by the clinicians within the hospital to view the radiology images and to read the radiology report. |
| IDS5/web | A slim version of the Sectra Workstation that can be used by remote clinics to view images and radiology reports. |
| IDS5/home | An at-home workstation of the diagnostics workstation that can be used by the radiologist over a low bandwidth connection. |
| IDS5/doc | A limited workstation that is used to scan radiology requests. |
| IDS5/send | A teleradiology workstation that is used to send examinations to teleradiology destinations. |
| IDS7/dx | New! A diagnostics workstation, based on the new software architecture. It contains tools for assisting the radiologist in making a diagnosis. |
To handle specific user needs it is also possible to activate Sectra developed add-ons for the I o handle spective asor add-on is thus an additional feature set that can be used on the Soctra Workstation. An was are add-ons on Sectra Workstation IDS5 but are included as ordinary features for IDS7. Examples:
| Add-on | Sectra Workstation IDS5 | Sectra Workstation IDS7 |
|---|---|---|
| Volume rendering (3D) | X | X |
| Clinical Application | ||
| Interface slots (2 additional) | X | |
| Dual monitor support | X | Included in IDS7 by default. |
| Multiframe support | X | Included in IDS7 by default. |
| Image cache | X | Included in IDS7 by default. |
| DICOM print support | X | |
| Image scanner support | X | |
| Basic document scanner | ||
| support | X | |
| Demonstration scheduling | X | |
| Nuclear medicine image | ||
| controls | X | |
| Patient CD | X |
Indications for Use:
The Sectra Workstation is intended for the manipulation and displaying of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc.; and teleconferencing.
Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
2
For primary diagnosis, post process DICOM "for presentation" images must be used.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Technological Characteristics:
The Sectra Workstation runs under the Windows 2000 Professional' and Windows XP Professional operating systems for PCs (as a minimum and depending upon system configuration) . The requirements on hardware are quite ordinary for a system used for displaying images. Most notably up to four monitors can be used.
Performance Data:
The subject device is developed according to ISO 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
Conclusion:
Similar to the predicate device, the Sectra Workstation does not contact the patient, nor does it control any life sustaining devices. Images and information being reviewed, processed, relayed, and or transmitted are interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention. The device and the predicate device share the same certification or conformance to performance standards and both function as Image Processing System (LLZ). Device failures, which might result in partial or failed transmissions, images, or data, may be recovered from storage or re-transmission after correcting the problem(s). Passwords are required for operation and to protect against unauthorized use.
Based on the information supplied in this Special 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.
Sectra Workstation IDS7 is not supported on Microsoft Windows 2000 Professional.
2 Windows NT is supported for IDS5/web.
3
Image /page/3/Picture/0 description: The image shows a circular seal or emblem. The seal features a stylized eagle with outstretched wings, a common symbol of the United States. Encircling the eagle is text, which appears to read "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
NOV - 7 2006
Sectra Imtec AB % Mr. Carl Alletto Official Correspondent OTech, Inc. 1600 Manchester Way CORINTH TX 76210
Re: K063093
Trade/Device Name: Sectra Workstation by Sectra Imtec AB Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 3, 2006 Received: October 10, 2006
Dear Mr. Alletto:
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 (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/3/Picture/10 description: The image is a circular logo with the letters "FDA" in the center. Above the letters, the numbers "1906-2006" are displayed. Below the letters, the word "Centennial" is written in a stylized font. The logo is surrounded by a dotted border.
Protecting and Promoting Public Health.
4
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 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.
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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
(Indications for Use Form)
510(k) Number: _K063093
Device Name: Sectra Workstation by Sectra Imtec AB
Indications for Use:
The Sectra Workstation is intended for the manipulation and displaying of medical images, including mammograms. It can show images from different modalities and interfaces to morious image storage and printing devices using DICOM or similar interface standards.
Device options make possible mammography reading, telecommunications; fast Demonstration; prosthesis CAD; 3-D and angiography, etc.; and teleconferencing.
Lossy compressed mammographic images are not intended for diagnostic review Lossy compressou manning with a be viewed with a monitor approved by FDA for viewing mammographic images.
For primary diagnosis, post process DICOM "for presentation" images must be used.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
ption Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
David R. Seymann
ision Sign-Off Division of Reproductive, Abdomin and Radiological Devices 510(k) Number