(75 days)
N/A
N/A
No
The description focuses on image distribution and display, using conventional computing platforms and operating systems from the late 1990s. There is no mention of AI, ML, or related concepts, nor any description of training or test sets typically associated with such technologies.
No
The device is a digital medical imaging distribution and display system used for diagnosis and image distribution, not for direct therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise," indicating its role in the diagnostic process.
Yes
The device is described as a "digital medical imaging distribution and display system" that operates on existing infrastructure and commercially available computer platforms and operating systems. It explicitly states it does not permanently store or produce original medical images, focusing on the conversion and display of DICOM images. This functionality is inherently software-based, relying on the processing and presentation of digital data. While it requires hardware (computers, network), the device itself, as described, is the software system performing the image handling and display functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Function: The Stentor PageView system is described as a "digital medical imaging distribution and display system." Its primary function is to distribute and display medical images (like X-rays, CT scans, etc.) for primary diagnosis and efficient distribution within a healthcare enterprise. It converts DICOM images for display.
- Lack of Biological Sample Analysis: There is no mention of this device analyzing biological samples or performing any tests on bodily fluids or tissues. Its input is digital image data (DICOM), not biological specimens.
Therefore, the Stentor PageView system falls under the category of medical imaging software/systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images.
Device Description
Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images.
Mentions image processing
The software used in this product is used to convert DICOM images to formats that can be displayed both within web browsers as well as stand-alone applications.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM 3.0
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The PageView components are always integrated into client applications. These PageView client applications are designed to be used by people who are involved in healthcare delivery. This includes physicians, medical technologists, administrative staffs, hospital information technology staffs, and people who will support and service the PageView products.
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)
Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s) (K number(s) and name(s); separate multiples with ";")
K982769 Mitra, Exhibit; K983815 Dome Imaging Systems, PACScache
Reference Device(s) (K number(s) and name(s); separate multiples with ";")
Not Found
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
OCT 25 1999
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the number '99', then '26', and ends with '98'. The handwriting appears somewhat cursive and the numbers are written closely together.
510(k) SUMMARY
In accordance with the provisions of the Safe Medical Device Act of 1990, m accordance with the provisional of safety and effectiveness information regarding the PageView software.
-
Company Identification 1.1
Stentor, Inc. 385 Oyster Point Blvd. Suite 8B South San Francisco, CA 94080 Tel: (650) 866-4100 Fax: (650) 866-4197 -
Official Correspondent 1.2
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA, USA, 94578-1116 (510) 276-2648 Tel: (510) 276-3559 Fax: Email: regman1@home.com -
Date of Submission 1.3
August 10, 1999 -
1.4 Device Name
Classification Name: Common/Usual Name: Proprietary Name:
PACS Teleradiology System Stentor PageView
- Substantial Equivalence 1.5
The PageView software is substantially equivalent to the Mitra, Exhibit
1
(K982769) and the Dome Imaging Systems, PACScache (K983815).
1.6 Device Description and Intended Use
Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images. For further information about the basic architecture of the system, please refer to the Stentor System Design Document Summary.
Intended Users: The PageView components are always integrated into client applications. These PageView client applications are designed to be used by people who are involved in healthcare delivery. This includes physicians, medical technologists, administrative staffs, hospital information technology staffs, and people who will support and service the PageView products.
1.7 Software Development
Stentor certifies that the PageView software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software used in this product is used to convert DICOM images to formats that can be displayed both within web browsers as well as stand-alone applications.
2
1.8 Safety and Effectiveness
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and indications for use.
The hardware components specified (but not supplied) are all "off the shelf" computer components.
Validation and Effectiveness:
Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers.
Substantial Equivalence:
The PageView software is a software package used to receive DICOM images, convert them to a web-browser compatible format, and to transfer those converted images to a viewing applet.
PageView is substantially equivalent to the Mitra Exhibit product, in that it receives DICOM images, converts them to wavelet format and displays them within a web browser. The intended use and technological characteristics of the system are virtually identical to Mitra Exhibit (K982769)or the Dome Imaging Systems PACScache (K983815). Any differences between the PageView software and the equivalent devices have no significant influence on safety or effectiveness.
It is our conclusion that there is no software component in the PageView product or hardware component which would be used in conjunction with the PageView product that we know of whose failure or latent design flaw would be expected to result in death or injury to a patient. Thus the "Level of Concern" of the Stentor PageView product is "minor".
3
1.9 Substantial Equivalence Chart
| Product Name | Mitra-Exhibit
(K982769) | Dome Imaging Systems
PACScache
(K983815) | Stentor-PageView
(this submission) |
|---------------------------------------------------|----------------------------|------------------------------------------------|---------------------------------------|
| Print to Paper Capability | Yes | Yes | Yes |
| Graphical Ul | Yes | Yes | Yes |
| Windows O.S. - Client | Yes | Yes | Yes |
| Uses Standard. Monitor | Yes | Yes | Yes |
| Scales Image to Display. | Yes | Yes | Yes |
| Image Input | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| Images stored on remote NT
server | Yes | Yes | Yes |
| Network Protocol | TCP-IP | TCP-IP | TCP-IP |
| Compression | Wavelet | J-Peg | Wavelet |
| Annotation | Yes | Yes | ત્ત્વ સ્ક્રિક |
| Image Measurement | Yes | No | Yes |
| Cine tool | Yes | Yes | Yes |
| Comparison Mode | Yes | Yes | Yes |
| Review Report from RIS | Yes | Yes | Yes |
| Designed for Use Inside &
Outside of Radiology | Yes | Yes | Yes |
| Flip / Rotate of Images | Yes | Yes | Yes |
| User Log In | Yes | Yes | Yes |
| Multiple Layout Options | Yes | Yes | Yes |
| WW/WL control & Pre-sets | Yes | Yes | Yes |
| Patient & Study Browser | Yes | Yes | Yes |
.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & WOMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 1999
Stentor, Inc. Gary Allesbrook C/o Regulatory Management Services 16303 Panoramic Way San Leandro, California 94578-1116
RE:
K992698 Stentor PageView Teleradiology System Dated: August 10, 1999 Received: August 11, 1999 Regulatory Class: I 21 CFR 892.2020/Procode: 90 LMD
Dear Mr. Allesbrook:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have have have have have We have reviewed your Section 510(i) houlder of the indications to use stated in the enclosure) to legally
determined the device is substantially equivalent for the enclosur determined the device is substant for the more processor of the enatorent date of the enational date of the marketed predicate devices marked in melse phone of this novel of on one of the provisions of the provisions of the provisions of the provisions of the negeral con Medical Device Amendments, or to devices that nave been receives market the do the general control.
Federal Food, Dog, and Cosmetic Act (Act). Your may, therefore, market th Federal Food, Drug, and Cosmetic Act (Ac). Tou may, the Act are activents for annual registration and cregistration, include provisions of the Act. The general controls provisions of the PRS mades of can be adulteration.
devices, good manufacturing practice, labeling, and prohibitions against misbr
lf your device is classified (see above) into either class III (Special Controls) or dass III (Premarket Approval), it may lf your device is classified (see above) into ether class in (rehearm (result in the contral) (e contract in the contraction in the comment in end be subject to such additional controls. Existing major regulation assumes ompliance with
Federal Regulations, Title 21, Parts 800 to 85. A substantially equivation Regulat Federal Regulations, Title 21, Factice requirements, as set forth in Custimanters (GS) for States
the Current Good Manufacturing Practice requirements, as set forth in the Fo the Current Good Manufacturing Pracice requirements, as set of the Crising of Sinnesgiations, the Frood and Medical Devices: General regulations Failure of the Conqly with the County with the Centrely in the Pesult in
Drug Administration (FDA) will verify such assumptions. Failu Drug Administration (FDA) will venty such assumply on the che vine ring var device in the Eederal
regulatory action. In addition, FDA may publish further announcering your o regulatory action. In addition, FDA may publish untitler and occisen dregondry of affect any obligation you
Register. Please note: this response to your premarket notifica Register. Please note: this response to your prematics now and the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification for This letter will allow you to begin marketing your device an your of your broad. In a classified in a classified in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your labeling regulation (21 CFR Part 801 and additionally for guestions on lf you desire specific advice in your device on on labelling legaler (21) 554-413. Additionally, for questions on
vitro diagnostic devices), please contact the Office of Co vitto diagnostic devices), please contact the Unice of Corrise of Compliance at (301) 594-4639. Also,
the promotion and advertising of your device, please contact the Offic the promotion and advertising of your eetch, pease continues on online to t (21 - 1). Other .
please note the regulation entitled, "Mistranding by reference to britison of S please note the regulation entilled, "Misting of reletice to prehided from the Division of Small Manufacturers
general information on your responsibilities under the Act . (1 general information on your responsibilities and the Act May 25 Stainternet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
K992698 510(k) Number (if known):
Stentor, PageView Device Name:
Indications For Use:
Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 901.109)
Over-the-Counter Use
Verid C. Sgem
(Division Sign-Off)
(Optional Format 1-2-96)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number: K992145
Medical Devices
510(k) Number K992645