(90 days)
Not Found
No
The summary describes standard image processing, viewing, and communication functions typical of a medical imaging workstation. There is no mention of AI, ML, or related concepts, nor are there details about training or test sets which would be expected for an AI/ML device.
No
The device is a software package for viewing, manipulating, and communicating medical images from devices like CT or MRI. It does not provide therapy or treatment.
No
The device is an image processing workstation software that receives and processes images, but it does not perform diagnosis itself.
No
The device is described as a software package that runs on "standard PC hardware" and "off-the-shelf standard computer components," implying it requires specific hardware to function, even if that hardware is not proprietary.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The EasyVision Workstation Release 6 processes and manipulates medical images (CT, MRI) obtained from scanning devices. It does not analyze biological samples.
- Lack of IVD characteristics: The description does not mention any analysis of biological specimens, chemical reactions, or diagnostic tests performed on samples.
The device is clearly described as an image processing workstation for medical images, which falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The EasyVision Workstation Release 6 is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. The Easy Vision Workstation Release 6 software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The device is a software package able to run on "off the shelf" hardware components. The system operating software is a standard Windows XP Professionel operating system. The application software can be divided in view, print, store and link functions. Communication with modalities such as MRI and CT and with archive systems, operates via a standardised DICOM protocol on top of a TCP/IP network.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanning devices, such as CT or MRI, or from image archives
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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
Philips Medical Systems
ો
I
Image /page/0/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" written in bold, sans-serif font above a shield-shaped emblem. The emblem features a circle with wavy lines across the middle, and four stars placed around the circle. The logo is presented in black and white.
S
DEC 1 9 2002
510 (k) Summary
Philips "EasyVision Workstation Release 6"
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| General Information | |
|---|---|
| Company Name: | Philips Medical Systems North America Company |
| Address: | 22100 Bothell Everett Highway 98021-8431 |
| Bothell Washington | |
| USA | |
| Contact Person | Lynn T. Harmer |
| Telephone Number: | 425-478-7312 |
| Prepared (date): | September 18, 2002 |
| Device Name: | Philips EasyVision Workstation Release 6 |
| Classification Name: | System, Image Processing |
| Regulation number | 892.2050 |
| Classification: | Class: |
| II | |
| ProCode: | 90 LLZ |
| Common/Usual Name: | Workstation |
| Predicate Devices: | Philips EasyVision Workstation |
1
Information Supporting Substantial Equivalence Determination II
System Description:
The device is a software package able to run on "off the shelf" hardware components. The system operating software is a standard Windows XP Professionel operating system. The application software can be divided in view, print, store and link functions. Communication with modalities such as MRI and CT and with archive systems, operates via a standardised DICOM protocol on top of a TCP/IP network.
Intended Use:
The product is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. The Easy Vision Workstation Release 6 software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.
Safety information:
No new hazards are introduced by the development of Easy Vision Workstation Release 6. Hazards known during the lifecycle of the Easy Vision Workstations are again considered and measurements are taken.
Substantial equivalence:
The Philips Easy Vision Workstation Release 6 is substantially equivalent to the Easy Vision Workstation systems (K920950).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other, with flowing lines below them.
Public Health Service
DEC 1 9 2002
od and Drug Administra 200 Corporate Boulevard Rockville MID 20850
Mr. Lynn T. Harmer Manager, Regulatory Submissions Philips Medical Systems North America Company 22100 Bothell Everett Highway BOTHELL WA 98021-8431
Re: K023137
Trade/Device Name: Philips Easy Vision Workstation Release 6 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ
Dated: September 19, 2002 Received: September 20, 2002
Dear Mr. Harmer:
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 (PMA), it may be subject to 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 (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 1000-1050.
3
Page 2
This letter will allow you to begin marketing your device as described in your 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 this 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" (21 CFR Part 807.97). 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. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
X02 3137
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
EasyVision Workstation Release 6 Device Name:
Indications for Use:
The EasyVision Workstation Release 6 is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. The Easy Vision Workstation Release 6 software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
Daniel A. Sigg
(Division Sign-Off) Division of Reproductive, Abdominal, Division of Reproductive, Abdominal
and Radiological Devices KO2331
(Optional Format 1-2-96)