(59 days)
Not Found
No
The document describes a software workstation for viewing and manipulating medical images, specifically mentioning interfacing with CAD devices but not incorporating AI/ML within the workstation itself. There is no mention of AI, DNN, or ML in the text.
No
The device is a software workstation for viewing and manipulating images, not for providing direct therapy.
Yes
The device is described as a "software workstation for viewing, manipulation, reporting and communication of digital mammography images... and other modality images," which assists trained professionals in interpreting diagnostic images, thereby making it a diagnostic device.
Yes
The device is described as a "software workstation" and a "software package" that runs on "standard information technology hardware and software." It interfaces with other devices using standard protocols but is itself presented as a software product.
Based on the provided information, the Philips MammoDiagnost VU is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description of the Philips MammoDiagnost VU clearly states its purpose is for "viewing, manipulation, reporting and communication of digital mammography images... and other modality images." This involves analyzing images of the body, not specimens taken from the body.
- The intended use and device description focus on image processing and display. The software is designed to work with medical images, not biological samples.
- There is no mention of analyzing biological materials. The input is imaging data, not blood, urine, tissue, or other bodily fluids or substances.
Therefore, the Philips MammoDiagnost VU falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS) workstation, not an IVD.
N/A
Intended Use / Indications for Use
Philips MammoDiagnost VU workstation software package is intended for viewing, manipulation, reporting and communication of digital mammography images (DICOM "For Presentation" images) as well as other modality images. It interfaces to mammography acquisition stations and image storage, printing and CAD devices using DICOM or similar interface standards.
Philips MammoDiagnost VU is a software workstation for viewing, manipulation, reporting and communication of digital mammography images (DICOM "For Presentation" images) and other modality images. It interfaces to image storage, printing and CAD devices using DICOM or similar interface standards.
The functional components include
- DICOM support
- Generic hanging protocols
- Mammography hanging protocol
- CAD overlays
- Double blind read workflow
- Automatic breast tissue alignment
- Background suppression at inversion
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Philips MammoDiagnost VU workstation software package is intended for viewing, manipulation, reporting and communication of digital mammography images (DICOM "For Presentation" images) as well as other modality images. It interfaces to mammography acquisition stations and image storage, printing and CAD devices using DICOM or similar interface standards. It uses and builds further on the Stentor iSite PACS v4.x software (Stentor is now a Philips owned company).
Philips MammoDiagnost VU workstation software package runs on standard information technology hardware and software. The proprietary software in the Philips MammoDisonost VU workstation software package uses a standard Microsoft Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Digital mammography images (DICOM "For Presentation" images) and other modality images.
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians and assistants.
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
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510(k) Summary
・・・・・・
Philips MammoDiagnost VU------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
විකාශය සිංහ මහතා විශ්වාදය විසින් පවත්වය පැවැත්වයි. ආශ්රිත
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. Sec. Saland . Sale and Controllar
| General Information | Bath : 1 : 1 : 143 : 13 : 26 : 26 : 26 : 26 : 26 : 26 : 26 : 20 : 26 : 26 : 20 : 20 : 26 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20 : 20
2017/08/2018 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name: | Philips Medical Systems North America Company
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| Address: | 22100 Bothell Everett Highway
Bothell Washington 98021-8431
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| Contact Person | Lynn. T. Harmer |
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| Device Name: | Philips MammoDiagnost VU - 11 - 11 - 11 - 11 - 11 - 11 - 11 -
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| Classification Name: | Picture Archiving and Communication System
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| Regulation number: | 11 VOIDU. 1191051. |
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| Common/Usual Name: | PACS Workstation 1 1 1 1 1 1 2 0 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
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Stentor Inc. (now Philips Healthcare Inc.), Arento
iSite PACS v 4.x 1 1 1 1 1 1 1 1 1 1 1 1 1 1 |
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1
.
Information Supporting Substantial Equivalence Determination II
System Description:
Philips MammoDiagnost VU workstation software package is intended for viewing, manipulation, reporting and communication of digital mammography images (DICOM "For Presentation" images) as well as other modality images. It interfaces to mammography acquisition stations and image storage, printing and CAD devices using DICOM or similar interface standards. It uses and builds further on the Stentor iSite PACS v4.x software (Stentor is now a Philips owned company).
is now a Philips owned company).
is now a Philips owned company).
Philips MammoDiamore VII includes and Sun Marc
Philips MammoDiagnost VU workstation software package runs on standard information technology hardware and software. The proprietary software in the Philips MammoDisonost VU workstation software package uses a standard Microsoft Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.
Intended Use:
Philips MammoDiagnost VU workstation software package is intended for viewing, manipulation, reporting and communication of digital mammography images (DICOM "For Presentation" images) as well as other modality images. It interfaces to mammography acquisition stations and image storage, printing and CAD devices using DICOM or similar interface standards.
Philips MammoDiagnost VU is used with high-resolution monitors suitable for screening and diagnostic mammography, for use in the USA these monitors must be FDA cleared. It is used by trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians and assistants.
General Safety and Effectiveness:
The MammoDiagnost VU software is specified, validated and tested under a registered ISO 13485 and 21 CFR Part 820 compliant Quality System.
The MammoDiagnost VU complies with the NEMA XR 22-2006, ("Quality Control Manual" Template for Manufactures of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography) and to the NEMA PS 3.2 DICOM set
The device labelling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. It is the user's responsibility to ensure that display quality, environmental lighting and other possible distractions are consistent with the clinical environment. lunakes (1917) .
The hardware components specified are all "off the shelf" computer components.
Conclusion:
The Philips MammoDiagnost VU does not introduce new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers the Philips MammoDiagnost VU to be substantially equivalent to the Stentor (Philips) iSite PACS v 4.x (K063267), the GE, Seno Advantage (K033400) and the Hologic, Secur View DX (K062107)
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems Nederland BV % Ms. Melissa J. DeGuia Senior Project Engineer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607
Re: K083740
Trade/Device Name: Philips MammoDiagnost VU Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 2, 2009 Received: February 3, 2009
Dear Ms. DeGuia:
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.
FEB 1 3 2009
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 concerning your device in the Federal Register.
3
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.
Sincerely yours,
Janine M. Morris
anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
ications for
510(K) Number (if known): K083740
Device Name:
Philips MammoDiagnost VU
1 2019 30 33
्
Indications for Use:
Philips MammoDiagnost VU is a software workstation for viewing, manipulati reporting and communication of digital mammography images (DICOM "For Presentation" images) and other modality images. It interfaces to image storage, printing and CAD devices using DICOM or similar interface standards
The functional components include
- · DICOM support
- Generic hanging protocols
- · Mammography hanging protoce
- CAD overlays
- Double blind read workflow
- Automatic breast tissue alignment
- Background suppression at inversion
Philips MammoDiagnost VU software nuns on standard information technology hardware and software. The proprietary software in the MammoDiagnost VU product uses a standard Microsoft Operating System and user interface. Communication and data exchange are done using standard TCPMP, DICQMand HL7 protocols
14-401-02-2015 11 13:15:53:33 In the USA, mammographic images may only be interpreted using FDA cleared monitors that offer at least 5 Mpixel resolution and meet other technical specifications reviewed and accepted by FDA.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 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) िस्तारिए 14 (Division (Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number