IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION

K081976 · Agfa Healthcare Corporation · LLZ · Jul 28, 2008 · Radiology

Device Facts

• Record ID: K081976
• Device Name: IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
• Applicant: Agfa Healthcare Corporation
• Product Code: LLZ · Radiology
• Decision Date: Jul 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The IMPAX MA3000 Diagnostic PACS Workstation is intended for use with regionally approved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality general imaging DICOM images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US). The IMPAX MA3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with FDA cleared monitors and only when viewing Lossless format images. The IMPAX MA3000 Diagnostic PACS Workstation is also intended for soft and hardcopy reading and diagnosis by Radiologists.

Device Story

IMPAX MA3000 is a diagnostic softcopy breast imaging workstation; enables display, review, processing, and printing of DICOM digital mammography (DR/CR), breast MR, and breast US images. Operated by radiologists in clinical settings; facilitates soft and hardcopy reading and diagnosis. Hardware includes Dell Precision 650 or Compaq xw6000 workstations, integrated Ethernet, and compatible high-resolution BARCO 5MP/3MP monitors. System supports multi-modality image selection and media interchange. Output allows radiologists to perform diagnostic assessments, potentially improving clinical decision-making through high-fidelity image visualization.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and functional comparison to predicate devices.

Technological Characteristics

PACS workstation; hardware includes Dell Precision 650 or Compaq xw6000; 10/100/1000 Ethernet; supports BARCO 5MP/3MP CRT/LCD monitors. Software enables DICOM image display, processing, and printing. No specific algorithm architecture or sterilization method described.

Indications for Use

Indicated for radiologists performing diagnostic or screening mammography and multi-modality general imaging, including breast MR and breast US, using DICOM images. Requires FDA-cleared monitors and lossless image formats for mammography viewing.

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

• Agfa IMPAX Client Embrace™ (K040555)
• McKesson Medical Imaging Company, Horizon Medical Imaging (K043146)

Submission Summary (Full Text)

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1081976

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

JUL 2 8 2008

Submitted by: Agfa Healthcare Corporation 10 South Academy Street Greenville, SC 29601

1. Date Prepared January 28, 2008

- 2. Contact Person Patrick Lynch Phone: [phone] FAX: [phone]
## 3. Device Name and Classification

IMPAX® MA3000 Trade Name: Classification Name: Picture archiving and communications system. Classification Panel: Radiology

> CFR Section: 21 CFR § 892.2050 Device Class: Class II Device Code: LLZ

### 4. Indications for Use

The IMPAX MA3000 Diagnostic PACS Workstation is intended for use with regionally approved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality general imaging DICOM images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US).

The IMPAX MA3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with FDA cleared monitors and only when viewing Lossless format images.

The IMPAX MA3000 Diagnostic PACS Workstation is also intended for soft and hardcopy reading and diagnosis by Radiologists.

#### 5. Substantial Equivalence

The predicate devices are: ·

Agfa IMPAX Client Embrace™ (later renamed MA3000), K040555, May 26, 2004.

McKesson Medical Imaging Company, Horizon Medical Imaging, K043146, January 4, 2005.

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# 6. Device Description

IMPAX MA3000 is a diagnostic softcopy breast imaging workstation with diagnostic print capability.

The following features are available:

· Display and printing of regionally approved DICOM DR Digital Mammography Images

(MG SOP class)

· Display and printing of regionally approved DICOM CR Digital Mammography Images

(CR SOP class)

The Hardware configuration of Embrace™ will consist of the following:

Dell Precision™ Workstation 650; System (Per Host Machine): Compaq xw6000

Number & Details of CPU's 1 or 2 CPU's depending on configuration

Hard Drive space: 40GB IDE

> CD-ROM: Yes

> > Floppy: Yes

Network interfaces: System comes with an integrated 10/100/1000 Ethernet adapter

Power Supplies: Default

> Chassis: Tower

Peripherals: Microsoft IntelliMouse or IntelliMouse Explorer; Keyboard

Embrace™ will support the following monitors:

- BARCO Mammography MeDis 5MP CRT monitor package MGD . 521M
- . BARCO Mammography 5MP and 3MP Flat Panel LCD's (EU)

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# 7. Comparison of Technological Differences:

Technological and functional characteristics of Agfa's MA3000 software are identical to those of Horizon Medical Imaging and Client Embrace. Both of these workstations allow easy selection, review, processing, filming and media interchange of multi-modity images from a variety of diagnostic imaging systems.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2008

Agfa HealthCare Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K081976

Trade/Device Name: IMPAX® MA3000 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 10, 2008 Received: July 11, 2008

### Dear Mr. Job:

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 vour 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.

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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 null on to COMP Don 2011 11: 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 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 100-1050.

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 10(x) marketed predicate device results in a classification for your device and this, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance a 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRF s Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276 3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small (0.40) 07.01.2015 10.00 Consumer Assistance at its toll-free number [phone] 01 [phone] or at its Internet address http://www.fda.gov/cdrf/industry/support/index.html U

Sincerely vours.

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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# Indications for Use

510(k) Number (if known): K08)976

Device Name: IMPAX® MA3000

Indications For Use:

The IMPAX MA3000 Diagnostic PACS Workstation is intended for use with regionally approved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality general imaging DICOM images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US).

The IMPAX MA3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with FDA cleared monitors and only when viewing Lossless format images.

The IMPAX MA3000 Diagnostic PACS Workstation is also intended for soft and hardcopy reading and diagnosis by Radiologists.

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)

Tom hitwhy
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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