(30 days)
Not Found
No
The description focuses on standard image display and conversion, with no mention of AI/ML terms or functionalities like analysis, interpretation, or automated detection.
No
The device is a software package for displaying radiology images, intended for diagnostic reading, not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" states that it is "to be used for display of digital radiology images." The "Device Description" explicitly states, "iSite Radiology is designed as a Diagnostic reading workstation." The "Intended User / Care Setting" also lists "Diagnostic reading workstation." These statements clearly indicate its use in diagnostics.
No
The device description explicitly states that the software is installed on a "Personal Computer equipped with the appropriate hardware" and uses "standard 'off-the-shelf' PC hardware." While the software is the core component, it requires specific hardware for its operation and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "medical image softcopy reading software package to be used for display of digital radiology images." This clearly indicates the device is for viewing and interpreting medical images, which are generated in vivo (within the living body) by imaging modalities like X-ray.
- Device Description: The description reinforces this by stating it's a "Diagnostic reading workstation" that receives and displays DICOM images.
- Lack of IVD Characteristics: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a patient's health. This device does not interact with or analyze biological samples.
The device is a medical image viewing and processing software, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Stentors' iSite Radiology is a medical image softcopy reading software package to be used for display of digital radiology images.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
iSite Radiology is designed as a Diagnostic reading workstation Site Radiology is dealghous as be marketed as software only, as well as packaged with standard PC hardware.
iSite Radiology is capable of receiving and displaying DICOM images.
Images sent to ISite Radiology are converted into formats suitable for mages sent to follo Racionage stored in a local cache viewing in its framowork, ansed by ISite Radiology to view JPEG and wavelet images follow known and accepted protocols.
Images sent to ISite Radiology can be viewed using an executable mages on that is installed on a Personal Computer equipped with the appropriate hardware.
ISite Radiology uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to ISite Radiology.
Mentions image processing
Not Found
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
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
DEC 0 5 2001
510(k) SUMMARY
KO/3630
In accordance with the provisions of the Safe Medical Device Act of 1990, Steator, Inc. is providing a summary of safety and effectiveness information regarding the ISite Radiology software.
-
Company Identification 1.1
Stentor, Inc. 385 Oyster Point Blvd. Suite 8B South San Francisco, CA 94080 Establishment Registration #2954704 Contact: Deanna Wiseman, Operations Manager Tel: (650) 866-4100 Fax: (650) 866-4197 -
1.2 Official Correspondent
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro CA USA 94578-1116 Tel: (510) 276-2648 Fax: (510) 276-3559 Email: regman 1 @home.com -
1.3 Date of Submission August 27, 2001
-
Device Name 1.4
Classification Name: Common/Usual Name: Proprietary Name:
PACS Soft-copy reading system iSite Radiology
- 1 .5 Substantial Equivalence
The iSite Radiology software is substantially equivalent to the Kodak, AutoRad (K955092) and the GE Advantage Windows Diagnostic X-RAY workstation (K942120) product.
1
Device Description and Intended Use
iSite Radiology is designed as a Diagnostic reading workstation Site Radiology is dealghous as be marketed as software only, as well as packaged with standard PC hardware.
iSite Radiology is capable of receiving and displaying DICOM images.
Images sent to ISite Radiology are converted into formats suitable for mages sent to follo Racionage stored in a local cache viewing in its framowork, ansed by ISite Radiology to view JPEG and wavelet images follow known and accepted protocols.
Images sent to ISite Radiology can be viewed using an executable mages on that is installed on a Personal Computer equipped with the appropriate hardware.
ISite Radiology uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to ISite Radiology.
Software Development 1.7
Stentor certifies that the ISite Radiology 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 developed for this product is used to provide diagnostic quality images and associated information to the indented users.
1.6
2
Safety and Effectiveness 1.8
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:
iSite Radiology software is a software package used to receive Images from the Stentor iSite Server. It provides the user diagnostic quality images and the tools to make a diagnosis.
ISite Radiology is substantially equivalent to the Cemax-Icon AutoRAd product, in that it receives DICOM images, displays them on Diagnostic Quality Monitors and provides the tools and associated information The intended use and technological required for diagnosis. characteristics of the system are virtually identical to Cemax-Icon AutoRAd (K955092) or GE Advantage Windows Diagnostic X-RAY workstation (K942120). Any differences between the ISite Radiology 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 ISite Radiology product or hardware component which would be used in conjunction with the ISite Radiology 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 ISite Radiology product is "minor".
3
Substantial Equivalence Chart 1.9
、
··
| Product Name | GE Advantage
Windows
(K942120) | (Kodak) Cemax-
Icon AutoRad
(K955092) | Stentor-ISite
Radiology
(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 | Yes |
| 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 U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 5 2001
Stentor, Inc. % Mr. Mark Job Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891 Re: K013630
Trade/Device Name: iSite Radiology Soft-Copy reading system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 19, 2001 Received: November 20, 2001
Dear Mr. Job:
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.
5
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 nredicate 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
of 1 Page 1
510(k) Number (if known): どこノ3630
Stentor, iSite Radiology Device Name:
Indications For Use:
Stentors' iSite Radiology is a medical image softcopy reading software package to be used for display of digital radiology 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 901.109)
OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K013630
510(k) Number