MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1

K033712 · Sectra-Imtec AB · LLZ · Dec 23, 2003 · Radiology

Device Facts

• Record ID: K033712
• Device Name: MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1
• Applicant: Sectra-Imtec AB
• Product Code: LLZ · Radiology
• Decision Date: Dec 23, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The Sectra IDS device is intended for the manipulation and displaying of x-ray 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. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Device Story

Sectra IDS5 Radiology Workstation with IDS5/mx.net is a software-based Picture Archiving and Communications System (PACS). It receives digital radiology images from various modalities via DICOM or similar standards. The system runs on Windows 2000/XP PCs and supports up to four monitors for visualization. It provides tools for mammography reading, 3-D reconstruction, angiography, and prosthesis CAD. Used by radiologists and medical staff in clinical settings to review, process, and transmit images. The device does not contact the patient or control life-sustaining equipment; it serves as a diagnostic aid where output is interpreted by trained professionals to inform clinical decision-making.

Clinical Evidence

No clinical data provided. The device is a software-based image processing system; substantial equivalence is supported by bench testing and adherence to established performance standards (DICOM 3.0, ISO 9001:2000).

Technological Characteristics

Software-based PACS running on Windows 2000/XP PC hardware. Supports up to four monitors. Interfaces via DICOM 3.0. Includes tools for 3-D rendering, angiography, and prosthesis CAD. Password-protected access control.

Indications for Use

Indicated for trained professionals (physicians, radiologists, nurses, technicians) for the manipulation and display of x-ray images, including mammograms, for diagnostic purposes.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Sectra IDS5 Radiology Workstation - Version 10 (K0033088)

Submission Summary (Full Text)

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K03 3712

DEC 2 3 2003

# 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

### Date Prepared:

December 16, 2003

### Submitter's Information:

Sectra Imtec AB Teknikringen 20 SE-583 30 Linköping Sweden Phone: [phone] Fax: [phone]

#### Trade Name, Common Name, Classification:

| Trade Name: | Sectra IDS5 Radiology Workstation with IDS5/mx.net |
|----------------------|----------------------------------------------------|
| 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: | K0033088 |
| Device: | Sectra IDS5 Radiology Workstation - Version 10. |

#### Device Description:

The IDS5 Radiology Workstation with IDS5/mx.net is mainly a software product. It is used for visualization and processing of digital radiology images. The system runs under the Window 2000 and Windows XP operating system. The requirements on hardware are quite ordinary for a system used for displaying images. Most notably up to four monitors can be used.

#### Indications for Use:

The Sectra IDS device is intended for the manipulation and displaying of x-ray 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.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

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## Technological Characteristics:

The IDS5 Radiology Workstation with IDS5/mx.net system will run on Windows 2000 and Windows XP operating system for PCs, (as a minimum and depending upon system configuration).

## 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 IDS5 Radiology Workstation with IDS5/mx.net 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 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the department's name encircling an emblem. The emblem consists of a stylized caduceus-like symbol, representing health and medicine, with three intertwined strands.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sectra Imtec AB % Mr. Carl Alletto OTech, Inc. 1600 Manchester Way CORINTH TX 76210

DEC 2 3 2003

Re: K033712

Trade/Device Name: Sectra IDS5 Radiology Workstation Version 10.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 21, 2003 Received: December 1, 2003

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 (PMA), 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 (OS) 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) 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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

Page 2

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# 510(k) Number: Ko 3 3712

Device Name: IDS (Image Display System) by Sectra Imtec AB

Indications For Use:

The Sectra IDS device is intended for the manipulation and displaying of x-ray 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.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

David A. Symm

# (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 801.109)

OR

Over -The-Counter Use

(Optional Format 1-2-96)