(85 days)
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No
The document describes a standard PACS workstation for displaying and processing medical images, with no mention of AI or ML capabilities. The focus is on image display, processing, and workflow features.
No
This device is a diagnostic PACS workstation intended for softcopy reading and diagnosis by Radiologists, not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for softcopy reading and diagnosis by Radiologists." The name "Embrace™ Diagnostic PACS Workstation" also includes "Diagnostic."
No
The device description explicitly lists hardware components (Dell Precision™ Workstation, Compaq xw6000, CPUs, Hard Drive, CD-ROM, Floppy, Network interfaces, Power Supplies, Chassis, Peripherals, and specific monitors) that are part of the Embrace™ system. This indicates it is a hardware and software system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Embrace™ Diagnostic PACS Workstation is a software and hardware system used for displaying and reviewing medical images (mammography, breast MR, breast US). It aids radiologists in interpreting these images for diagnosis.
- Lack of Biological Sample Analysis: The device does not analyze biological samples. Its function is centered around the visualization and manipulation of medical images.
Therefore, while it is a diagnostic device used in healthcare, it falls under the category of medical imaging workstations rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
The Embrace™ DS3000 Diagnostic PACS Workstation is also intended for softcopy reading and diagnosis by Radiologists.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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)
· 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) .
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
digital mammography, Breast MR, Breast US
Anatomical Site
Breast
Indicated Patient Age Range
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Intended User / Care Setting
Radiologists / Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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
-
- 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