R2 BREAST IMAGING WORKSTATION

K051743 · R2 Technology, Inc. · LLZ · Jul 25, 2005 · Radiology

Device Facts

• Record ID: K051743
• Device Name: R2 BREAST IMAGING WORKSTATION
• Applicant: R2 Technology, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jul 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The R2 Breast Imaging Workstation is intended for the manipulation and display of x-ray images, including the primary reading of mammograms. It can show images from different acquisition/scanning devices and interfaces to various image storage and printing devices using DICOM or similar interface standards. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians and assistants. 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.

Device Story

R2 Breast Imaging Workstation is a combination of hardware and software for viewing/manipulating x-ray images; specifically mammograms. Device interfaces with acquisition/scanning devices, storage, and printing systems via DICOM or similar standards. Used by radiologists and trained medical staff in clinical settings. Software plug-in integrates with workstation via Clinical Application Interface (CAI). Output displayed on FDA-approved monitors for diagnostic review. Facilitates primary reading of mammographic images; supports clinical decision-making by providing high-quality image visualization.

Clinical Evidence

Bench testing only. Device undergoes design verification tests for conformance with specifications.

Technological Characteristics

Commercially available imaging workstation hardware with R2 plug-in software. Connectivity via DICOM or similar interface standards. Supports image manipulation and display. No specific materials or energy sources listed beyond standard workstation components.

Indications for Use

Indicated for trained professionals (physicians, radiologists, nurses, medical technicians, assistants) for manipulation and display of x-ray images, including primary reading of mammograms. Contraindicated for diagnostic review using lossy compressed mammographic images.

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 Imaging Workstation IRS5/mx.net (K033712)

Submission Summary (Full Text)

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K051743-*

2 Technology, Inc. R2 Breast Imaging Workstation 510(k) Premarket Notification CONFIDENTIAL

JUL 25 2005

| Section 2.1 | 510(k) Summary<br>Prepared May 31, 2005 |
|-------------------|----------------------------------------------------------------------------------------------------------|
| Submitted by: | R2 Technology, Inc.<br>1195 W. Fremont Avenue<br>Sunnyvale, CA 94087 |
| Contact Person: | Denise F. Gottfried MS/MBA RAC<br>Vice President of Regulatory, Quality, Clinical and<br>Medical Affairs |
| Product Name: | R2 Breast Imaging Workstation |
| Common Name: | Medical Imaging Workstation |
| Classification: | LLZ; Class II; CFR 21 892.2050 |
| Predicate Device: | Sectra Imaging Workstation IRS5/mx.net<br>(K033712) |

#### Description of Device:

The R2 Breast Imaging Workstation is a combination of dedicated computer software and hardware. The workstation consists of a commercially available imaging workstation and the R2 plug-in software application, which is compatible with the workstation through a Clinical Application Interface (CAI).

#### Intended Use:

The R2 Breast Imaging Workstation is intended for the manipulation and display of x-ray images, including the primary reading of mammograms. It can show images from different acquisition/scanning devices and interfaces to various image storage and printing devices using DICOM or similar interface standards. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians and assistants.

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.

#### Comparison with Predicate Devices:

The submission device and the predicate device have the same intended use and equivalent technological specifications. All devices support DICOM protocol for communication of images and other medical imaging devices.

#### Studies:

The R2 Breast Imaging Workstation will undergo design verification tests for conformance with specifications.

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#### 30-Dec-2004 (Ver. 2) l'agc 1 of 1

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# Third Party Review Quality Assessment

| Section 1 - Submission Information | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------|-----------------------|-----------|--------------|
| 510(k) No.: | K051743 | Third Party Organization: | Under Water L.b., Inc | | |
| Third Party's Primary Reviewer(s): | Morton Simon Christensen | | | | |
| ODE/OIVD Division: | DEARD | Branch/Team: | RADB | | |
| Section 2 - 510(k) Decision | | | | | |
| Third party recommendation: | SE <span style="text-decoration: overline;">✓</span> NSE ____ Other (specify): _________ | | | | |
| ODE/OIVD final decision: | SE <span style="text-decoration: overline;">✓</span> NSE ____ Other (specify): _________ | | | | |
| Section 3 - Assessment of Third Party Review | | | | | |
| Review Element | Rating (check one) | | | | |
| | Adequate | Minor Issue(s) | Major Issue(s) | | |
| a. Determination of device eligibility for third party review | | ✓ | | | |
| b. Extent of pre-submission consultation with ODE/OIVD division | | | Moderate | | |
| c. Organization and format of review documentation | | | | | |
| d. Determination of 510(k) administrative completeness (screening review) | ✓ | | | | |
| e. Summary of device characteristics, intended use, and performance (including accessories, if applicable) and reason for 510(k) submission | ✓ | | | | |
| f. Comparison to legally marketed devices—identification and analysis of key similarities and differences | ✓ | | | | |
| g. Rationale for conclusions and recommendation | | | ✓ | | |
| h. Use of guidance documents and standards | ✓ | | | | |
| i. Resolution of 510(k) deficiencies and FDA requests for additional information | | ✓ | | | |
| j. Scope of reviewer expertise and use of consulting reviewers | | | ✓ | | |
| k. Other (specify): | | | | | |
| Comments (explanation of ratings/issues): | | | | | |
| Section 4 - ODE/OIVD Assessor Information | | | | | |
| Assessed by: | K Chakrubart L | Date: | 7/19/05 | Tel. No.: | 301-594-1212 |
| Routing: Division--Clip completed assessment (this page only) to inside front cover of 510(k). | | | | | |

Routing: Division--Clip completed assessment (this page only) to inside front cover of 510(K).

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Image /page/2/Picture/1 description: The image shows a circular seal with the Department of Health & Human Services - USA text around the perimeter. In the center of the seal is a stylized eagle-like symbol with three curved lines extending from its head, resembling wings or feathers. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

R2 Technology, Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Service Underwriters Laboratories, Inc. 1655 Scott Boulevard

SANTA CLARA CA 95050-4169

Re: K051743

JUL 25 2005

Trade/Device Name: R2 Breast Imaging Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 14, 2005 Received: July 18, 2005

Dear Mr. Christensen:

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.

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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and and a . The FDA finding of substantial equivalence of your device to a legally prematication - 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 rryou doins office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 77). I Canall Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

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R2 Technology, Inc. R2 Breast Imaging Workstation 510(k) Premarket Notification CONFIDENTIAL

### Section 2.2 Indications For Use

## Device Name: The R2 Breast Imaging Workstation

The R2 Breast Imaging Workstation is intended for the manipulation and display of x-ray images, including the primary reading of mammograms. It can show images from different acquisition/scanning devices and interfaces to various image storage and printing devices using DICOM or similar interface standards. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians and assistants.

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.

*Prescription Use*

David A. Lynn

(Division Sign-Off) Division of Reproductive, Abdomis and Radiological Devices "\\k} Number _________________________________________________________________________________________________________________________________________________________________