← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K040555 # IMPAX CLIENT EMBRACE (K040555) _Agfa Corp. · LLZ · May 26, 2004 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K040555 ## Device Facts - **Applicant:** Agfa Corp. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** May 26, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The Embrace™ Diagnostic PACS Workstation is intended for softcopy reading and diagnosis by Radiologists. It is also 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 Embrace™ DS3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with EDA approved monitors and only when viewing Lossless format images. ## Device Story Embrace™ Diagnostic PACS Workstation; softcopy reading/diagnosis tool for radiologists. Inputs: DICOM 'For Presentation' images from digital mammography, breast MR, and breast US modalities. Operation: workstation displays multi-modality images for review, processing, and filming. Context: clinical radiology environment. Output: visual display of medical images on high-resolution monitors (e.g., BARCO 5MP/3MP). Benefit: facilitates diagnostic review of breast imaging studies. ## Clinical Evidence No clinical data provided; substantial equivalence based on technological and functional comparison to predicate device. ## Technological Characteristics Workstation hardware: Dell Precision 650 or Compaq xw6000; 1-2 CPUs; 40GB IDE HDD; Ethernet connectivity. Monitors: BARCO Mammography MeDis 5MP CRT or 5MP/3MP Flat Panel LCDs. Software: DICOM-compliant image display and processing. Sterilization: N/A. ## Regulatory 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 ([K033400](/device/K033400.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K040553 ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Submitted by: Agfa Corporation 10 South Academy St. Greenville, SC 29602-9048 #### 1. Date Prepared February 25, 2004 - 2. Contact Person Phil Cuscuna Phone: (519) 746-2900 FAX: (519) 746-3745 #### 3. Device Name and Classification Embrace™ Workstation Trade Name: Picture archiving and communications system. Classification Name: Classification Panel: Radiology > CFR Section: 21 CFR § 892.2050 Device Class: Class II Device Code: LLZ #### 4. Intended Use The Embrace™ Diagnostic PACS Workstation is intended for softcopy reading and diagnosis by Radiologists. It is also 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). #### 5. Substantial Equivalence The predicate devices is General Electric Medical Systems' Seno Advantage (FDA's Clearance number: K033400; FDA's clearance date: 12/04/2003). #### 6. Device Description IMPAX Client Embrace™ delivers a diagnostic softcopy breast imaging workstation for the Women's Care initiative at AGFA. The following features are available: · Display of regionally approved DICOM DR Digital Mammography Images (MG SOP class) · Display of regionally approved DICOM CR Digital Mammography Images (CR SOP class) {1}------------------------------------------------ - · Embrace™ product branding The Hardware configuration of Embrace™ will consist of the following: | System (Per Host Machine): | Dell Precision™ Workstation 650;
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) . ### 7. Comparison of Technological Differences: Technological and functional characteristics of the Agfa's Embrace™ software are identical to those of Seno Advantage. Both of these workstations allow easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH &" is arranged vertically along the left side of the logo. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## MAY 2 6 2004 Agfa Corporation % Mr. Phil Cuscuna Regulatory Affairs of the Americas Agfa Health Carc 455 Philip Street Waterloo, Ontario, N2L 3X2 CANADA Re: K040555 Trade/Device Name: IMPAX® DS3000 Client Embrace Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 16, 2004 Received: March 2, 2004 Dear Mr. Cuscuna: 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 proor 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 concerting 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 (FR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ 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 | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C. Brygdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure Page 2 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K040555 Device Name: IMPAX® DS3000 CLIENT EMBRACE Indications For Use: The Embrace™ DS3000 Diagnostic PACS Workstation is intended for use with rno Embraoo ved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality images (1800) images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US). The Embrace™ DS3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with EDA approved monitors and only when viewing Lossless format images. The Embrace™ DS3000 Diagnostic PACS Workstation is also intended for softcopy 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) Nancy Brogdon (Division Sign-Off) Division of Reproductive, Abdominel, and Radiological Devices R040555 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K040555](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K040555) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com