DR SYSTEMS PACS, RELEASE 6.1

K041935 · Dr Systems, Inc. · LLZ · Aug 16, 2004 · Radiology

Device Facts

• Record ID: K041935
• Device Name: DR SYSTEMS PACS, RELEASE 6.1
• Applicant: Dr Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The DR Systems PACS, Release 6.1 is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. The DR Systems PACS interfaces to various storage and printing devices using DICOM or similar interface standards. The DR Systems PACS displays, stores, prints, and telecommunicates images from a number of medical modalities, including but not limited to MRI, CT, US, PET, DXA (bone densitometry), imaging, computed radiography, digital radiography, digitized films, digital photographs, mammographic images, and processed data from FDA-cleared third party image processing systems, including FDA-cleared systems for computer-aided detection and advanced image processing (e.g. 3-D processed images such as those produced by Voxar Corp.). Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.

Device Story

DR Systems PACS Release 6.1 is a multi-modality PC-based review workstation for radiology departments. Inputs include DICOM-compliant medical images from modalities (CT, MR, XR, RF, XA, CR, DX, MG, NM, PET, US, SC) and processed data from third-party CAD/advanced processing systems. System provides tools for image display, lossless/lossy compression (JPEG/JPEG2000), archiving, and printing. Operated by radiologists and clinical staff in hospital/clinic settings. Features include a software warning to ensure all image series are viewed before marking exams as read. Output is displayed on high-resolution monitors for diagnostic interpretation. System facilitates clinical decision-making by providing integrated access to multi-modality images and reports, improving workflow efficiency and diagnostic accuracy.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, risk analysis, and design verification/validation processes to ensure performance comparable to predicate devices.

Technological Characteristics

PC-driven workstation; color flat panel and high-resolution CRT/flat panel monitors; standard keyboard/mouse input; optional microphone. Supports DICOM standards for image storage, printing, and communication. Software-based image processing and compression (JPEG, JPEG2000).

Indications for Use

Indicated for clinical viewing, processing, and management of medical images from modalities including MRI, CT, US, PET, DXA, CR, DR, and mammography. Intended for use by radiologists and clinicians for diagnostic interpretation. Contraindicated for primary diagnostic interpretation of lossy compressed mammographic images unless specifically approved for digital mammography.

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

• Seno Advantage Windows Review Workstation (K033400)
• Sectra IDS5 Radiology Workstation (K033712 as modified by K040376)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a handwritten text that reads "Koy 1935". The text is written in a cursive style with thick, dark strokes, giving it a bold appearance. A horizontal line is present beneath the text, possibly indicating an underline or a separation from other content. The overall impression is that of an old document or signature.

# AUG 1 6 2004

#### 510(k) Summary of Safety and Effectiveness 6

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87 (h).

# 1. Identification of submitter:

| Name: | Kimberly J. Meade |
|----------------|---------------------------------------------------------------|
| Title: | Manager, Quality Assurance |
| Address: | DR Systems<br>10140 Mesa Rim Road<br>San Diego, CA 92121-2914 |
| Phone: | 858.625.3344 x418 |
| Fax: | 858.625.3334 |
| Date Prepared: | July 16, 2004 |

## 2. Identification of Product:

| Device name: | DR Systems PACS, Release 6.1 |
|-----------------|---------------------------------------------------------------|
| Classification: | 21 CFR Section 892.2050 |
| Manufacturer: | DR Systems<br>10140 Mesa Rim Road<br>San Diego, CA 92121-2914 |

## 3. Marketed Devices

The DR Systems product is substantially equivalent to the devices listed below:

| Model: | Seno Advantage Windows Review Workstation |
|-----------------|-------------------------------------------|
| Manufacturer: | General Electric Medical Systems |
| 510 (k) Number: | K033400 |
| Model: | Sectra IDS5 Radiology Workstation |
| Manufacturer: | Sectra Imtec AB |
| 510 (k) Number: | K033712 as modified by K040376 |

# 4. Device Description:

The DR Systems Dominator Reading Station is a multi-modality PC-driven review workstation. It includes a color flat panel monitor and two or more high-resolution monitors, which may be high resolution CRT's or flat panel monitors. A standard keyboard is provided as well as a standard mouse. Optionally, a microphone may be attached.

DR Systems also provides components as described in the DR Systems User Guide, including:

DR Systems, Inc. Original 510 (k)

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- Ambassador Viewing Station Software typically used by referring . doctors for viewing images, playing audio, or viewing reports, but not used for primary reading.
- Communicator Web Distribution Server. .
- Guardian Archive System and optional DVD jukebox or EMC Centera . archive.
- Catapult Technologist Workstation—for image and data input and . editing as required.
- Universal Manager Workstations-primarily used by clerks for . medical records and report management.

The DR Systems PACS, Release 6.1, provides the following features to the radiologist:

- DR Systems viewing software provides simple tools to enable display of any . digital image at the same resolution as the initial acquired digital image, independent of the monitor matrix size.
- DR Systems provides several DICOM-compliant methods of lossless and . lossy image compression (JPEG2000 and JPEG).
- The DR Systems PACS outputs DICOM medical image data to printers that . adhere to appropriate regulatory standards.
- DR Systems archives medical imaging data in DICOM format on appropriate . media (DVD, RAID servers, EMC Centera or other computer storage systems) that are designed to prevent data loss.
- DR Systems provides a software warning that identifies any image series . where any image was not viewed prior to marking an examination as read, in order to prevent the reading physician from completing interpretation of an exam while inadvertently failing to view all images.
- DR Systems enables storage and reading of digitized images, including film-. screen mammograms .

The DR Systems PACS is positioned to be the system of choice for all users of the following DICOM imaging modalities: CT, MR, XR, RF, XA, CR, DX, MG, NM, PET, US, SC.

# 5. Indications for Use

The DR Systems PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. The DR Systems PACS interfaces to various storage and printing devices using DICOM or similar interface standards.

DR Systems, Inc. Original 510(k)

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The DR Systems PACS displays, stores, prints, and telecommunicates images from a number of medical modalities, including but not limited to MRI, CT, US, PET, DXA (bone densitometry), nuclear imaging, computed radiography, digital radiography, digitized films, digital photographs, mammographic images, and processed data from FDA-cleared third party image processing systems, including FDA-cleared systems for computer-aided detection and advanced image processing (e.g. 3-D processed images such as those produced by Voxar Corp.).

Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.

## 6. Comparison with Predicate Devices

The DR Systems product is substantially equivalent to the following workstations used by radiologists:

| Model: | Seno Advantage Windows Review Workstation |
|-----------------|-------------------------------------------|
| Manufacturer: | General Electric Medical Systems |
| 510 (k) Number: | K033400 |
| Model: | Sectra IDS5 Radiology Workstation |
| Manufacturer: | Sectra Imtec AB |
| 510 (k) Number: | K033712 as modified by K040376 |

Each of these workstations allows easy selection, review, processing, archive, printing, and media interchange of multi-modality medical images from a variety of diagnostic imaging systems.

### 7. Conclusions

The DR Systems PACS and information management products provide specific features to integrate seamlessly into the radiology department workflow. The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes. The DR Systems product provides images comparable to the predicate devices.

DR Systems, Inc. Original 510(k)

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Image /page/3/Picture/1 description: The image shows a logo with a circle of dots on the left side and three curved lines on the right side. The curved lines appear to be stylized representations of something like waves or feathers. The logo has a simple, minimalist design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 6 2004

Ms. Kimberly J. Meade Manager, Quality Assurance DR Systems, Inc. 10140 Mesa Rim Road SAN DIEGO CA 92121

Re: K041935

Trade/Device Name: DR Systems PACS, Release 6.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: July 16, 2004 Received: July 19, 2004

Dear Ms. Mcade:

We have reviewed your Section 510(k) premarket notification of intent to market the device Wo have rottowed your betermined 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 that I DA has made a ceret 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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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin manteling your antial equivalence of your device to a legally premarket notification. The PDA miding of bassification 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 acvies for your and 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 Additionally, for questions on the p-4639. Also, please note the regulation entitled, "Misbranding Office of Compliano at (2017) 2211 Part 807.97) you may obtain. Other general by received to promative netitions under the Act may be obtained from the Division of Small miormation on your responsional 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. Bugdon

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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#### Indication(s) for Use Statement 5

To be assigned by FDA 510(k) Number:

DR Systems PACS, Release 6.1 Device Name:

Indications for Use:

The DR Systems PACS, Release 6.1 is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. The DR Systems PACS interfaces to various storage and printing devices using DICOM or similar interface standards.

The DR Systems PACS displays, stores, prints, and telecommunicates images from a number of medical modalities, including but not limited to MRI, CT, US, PET, DXA (bone densitometry), imaging, computed radiography, digital radiography, digitized films, digital photographs, mammographic images, and processed data from FDAcleared third party image processing systems, including FDA-cleared systems for computer-aided detection and advanced image processing (e.g. 3-D processed images such as those produced by Voxar Corp.).

Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carinda A. Ingram

DR Systems, Inc. Original 510 (k)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041935

000017