(80 days)
Not Found
No
The document describes a medical diagnostic workstation for viewing and manipulating images, including displaying CAD markers from other FDA-approved devices. It does not mention any AI or ML capabilities for image analysis or interpretation.
No
The device is described as a medical diagnostic workstation for viewing, manipulating, communicating, reporting, and storing medical images, primarily for interpretation by trained physicians. It does not perform any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "display, manipulation and interpretation of lossless compressed or noncompressed mammography images and diagnostic mammography". The term "diagnostic mammography" indicates its use in diagnosing medical conditions.
No
While the device is described as "essentially a software product," the device description explicitly states it "includes two high-resolution gray scale monitors (FDA approved/cleared for Mammography), or any FDA-cleared mammography monitor, 3button mouse, keyboard and keypad." This indicates the device includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "medical diagnostic workstation for viewing, manipulation, communication, reporting and storage of medical images and data." It is used by trained physicians for "display, manipulation and interpretation of lossless compressed or noncompressed mammography images and diagnostic mammography, as well as any other DICOM multi-modality image." This describes a system for processing and displaying medical images, not for performing tests on biological samples.
- Device Description: The device is described as "essentially a software product" that accepts and displays images. It includes monitors, a mouse, keyboard, and keypad. This aligns with an image viewing and manipulation system, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests to detect diseases or conditions based on the analysis of these samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device's function is centered around the display and manipulation of medical images, which falls under the category of medical imaging software or workstations.
N/A
Intended Use / Indications for Use
The MammoReport" is a medical diagnostic workstation for viewing, manipulation, communication, reporting and storage of medical images and data on exchange media including mammography images. It interfaces to various image storage and printing devices using DICOM or similar interface standards.
The MammoReport145 used with FDA cleared monitors may be used by trained physicians for display, manipulation and interpretation of lossless compressed or noncompressed mammography images and diagnostic mammography, as well as any other DICOM multi-modality image. CAD markers created by FDA approved devices may be displayed.
Product codes
LLZ
Device Description
The MammoReport" is essentially a software product. The software is used to accept images and CAD markers, directly intended for display (e.g. DICOM MG for presentation). The MammoReport"148 is a multi-modality review workstation used for presentation and manipulation of medical images including digital mammography images. It includes two high-resolution gray scale monitors (FDA approved/cleared for Mammography), or any FDA-cleared mammography monitor, 3button mouse, keyboard and keypad. The system will use lossless compression or no compression at all when displaying mammography images.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants, typically use the MammoReport"
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Siemens Medical Solutions, Inc Traditional 510(k) for MammoReportPlus
Ko42868
1 of 2
MammoReportPlus JAN - 6 2005 510(k) Summary
| Product Name: | MammoReportPlus |
|---|---|
| Product Classification Name: | Picture Archiving and Communications System |
| Product Classification Code: | LLZ CFR Section: 892.2050 |
| Classification Panel: | Radiology Class II |
| Manufacturer: | Siemens AG |
| Medical Solutions | |
| Henkestrasse 127 | |
| D-91052 Erlangen | |
| Germany | |
| Contact Person: | Debbie Peacock, Technical Specialist Regulatory Affairs |
| Telephone: (610) 448-1773 | |
| Fax: (610) 448-1787 | |
| Date Prepared: | October 15, 2004 |
MammoReport" ws soft copy review station (originally a part of the Predicate Device: overall system, P030010, Siemens MAMMOMAT Novation FFDM system cleared on 8/20/04).
Device Description: The MammoReport" is essentially a software product. The software is used to accept images and CAD markers, directly intended for display (e.g. DICOM MG for presentation). The MammoReport"148 is a multi-modality review workstation used for presentation and manipulation of medical images including digital mammography images. It includes two high-resolution gray scale monitors (FDA approved/cleared for Mammography), or any FDA-cleared mammography monitor, 3button mouse, keyboard and keypad. The system will use lossless compression or no compression at all when displaying mammography images.
1
Ko42 868
Siemens Medical Solutions, Inc Traditional 510(k) for MammoReportPlus
The minimum computer requirements are:
- . Windows XP Operating system
- . Intel CPU with a clock rate of 2.2 GHz or greater
- . 2.0 GB RAM or greater
- . 70 GB hard drive or greater, operation at 160 Mbs or greater
- CD-ROM/R/RW, DVD
- 10/100/1000 Base Network interface .
Summary of Technological Characteristics of the Devices Compared to the Predicate
The proposed syngo MammoReport" 108 soft copy review station combines the same ability for multimodality viewing with the Windows based operating system using a Siemens syngo graphical user interface (GUI) as is contained in the cleared predicate Leonardo Multimodality Workstation (K040970).
In addition, the proposed device contains the same ability to receive and display CAD markers from an approved device, as well as the ability to view multimodality and mammography images as the cleared predicate device, the Sectra IDS5 Workstation (K040376).
In addition to the cleared CRT monitors previously described in the original Siemens Mammomat Novation PMA submission, P030010, any FDA cleared TFT displays may be used as described in this PMN.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stripes extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 2005
Ms. Debra Peacock Technical Specialist, Regulatory Submissions Siemens Medical Systems, Inc. 51 Valley Stream Parkway, E-50 MALVERN PA 19355
Re: K042868 Trade/Device Name: MammoReportPlus Softcopy Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 9, 2004 Received: December 10, 2004
Dear Ms. Peacock:
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 / to 5 requirements, moraling 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter with cation. The FDA finding of substantial equivalence of your device to a legally promated 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 If you atte 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 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
Sincercly yours,
Nancy C. Brogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 1.1
510(k) Number (if known): K042868
Device Name: MammoReport\textsuperscript{Plus} Softcopy Workstation
Indications for Use
The MammoReport"]]s is a medical diagnostic workstation for viewing, manipulation, communication, reporting and storage of medical images and data on exchange media including mammography images. It interfaces to various image storage and printing devices using DICOM or similar interface standards.
The MammoReport 145 used with FDA cleared monitors may be used by trained physicians for display, manipulation and interpretation of lossless compressed or noncompressed mammography images and diagnostic mammography, as well as any other DICOM multi-modality image. CAD markers created by FDA approved devices may be displayed.
Trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants, typically use the MammoReport"his
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042868
Prescription Use V OR Over-The-Counter Use __
(Per 21 CFR 801.109)
CONFIDENTIAL