(72 days)
Not Found
No
The description focuses on standard image management and processing functions, with no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data.
No
The device is a medical image management software package intended for the acquisition, management, distribution, and display of medical images, not for providing therapy.
No
The device is described as a software package for image acquisition, management, distribution, and display, with features for reviewing and processing images. It does not perform diagnostic functions itself, but rather manages and presents information for review by a human.
Yes
The device description explicitly states it is a "software package" and lists various software components. There is no mention of any accompanying hardware that is part of the device itself. While it interacts with medical devices for image acquisition, the Telemis-Medical solution is presented as the software managing these images.
Based on the provided information, the Telemis-Medical solution is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the acquisition, management, distribution, and display of medical images. This is related to imaging and data management, not the analysis of biological samples or specimens to provide diagnostic information about a patient's health status.
- Device Description: The description focuses on software components for handling and processing images. It doesn't mention any interaction with biological samples, reagents, or laboratory procedures.
- Input: The input is digital medical images, not biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological material. There are no references to laboratory tests, assays, or diagnostic measurements derived from biological samples.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Telemis-Medical solution deals with the management and display of images generated by other medical devices (like imaging scanners), not with the analysis of biological samples.
N/A
Intended Use / Indications for Use
The Telemis-Medical solution is a software package intended for the acquisition, management, distribution and display of medical images within the healthcare system. It can be marketed as software only, as well as packaged with standard PC hardware. It was developed with the Java® technology that allows the software to run on every operating system implementing a Java Virtual Machine Environment (f.i. Windows, MacOS, Unix). It communications using the standard TCP/IP network protocol.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The Telemis-Medical Solution is a Medical Image Management software package designed to perform required functions for the import, storage, archive, distribution, review, analysis of digital medical images in DICOM 3.0 and other formats. The Telemis Medical Solution consists of the TM-AutoAcquisition. TM-Worklist. TM-Server. TM-Reception, TM-ReceptionHE, TM-Reception Lite, TM-Home, TM-Link and TM-Publisher.
TM-AutoAcquisition acquires image studies from medical devices, converts them into secure multimedia documents and sends them to the TM-Server. The TM-Worklist is used by the TM-AutoAcquisition to validate patient information. The TM-Server manages documents and security permissions. The TM-Reception allows authenticated users to retrieve, manage, review and process their image documents. The TM-ReceptionHE is an enhanced TM-Reception that provides users with extra image processing features. The TM-Reception Lite allows users to manage and review local image documents. The TM-Home delivers TM-Reception's features for personal use. The TM-Link provides transparent integration between Telemis-Medical and Electronic Patient Record system. The TM-Publisher makes image study summary available on CD-ROM, paper or e-mail.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare system
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
Ko3 2/5 7
SEP 2 4 2003
510(k) SUMMARY
Company Identification:
Telemis S.A. Avenue du Grand Cortil, 34 B-1348 Louvain-la-Neuve Belgium Phone: +32-10-48 00 11 Fax: +32-10-48 00 20
Official Correspondent:
Eric Thibau. European Certification Partners, Inc. 7560 Lindbergh Drive Gaithersburg, MD 20879 FAX: (240) 631-8228 (240) 631-8558 Tel:
Date Summary Prepared:
September 1, 2002
Name of the Device:
| Trade Name: | Telemis-Medical |
|---|---|
| Common name: | PACS |
| Classification name: | Picture Archiving and Communication System |
Predicate Device:
| Name of the device: | iSite Radiology |
|---|---|
| 510(K) Number: | K013630 |
| Company: | Stentor, Inc. |
| 385 Oyster Point Blvd., Suite 8B | |
| Establishment Registration #2954704 | |
| Tel: (650) 866-4100 | |
| Fax: (650) 866-4197 |
Device Description:
The Telemis-Medical Solution is a Medical Image Management software package designed to perform required functions for the import, storage, archive, distribution, review, analysis of digital medical images in DICOM 3.0 and other formats. The Telemis Medical Solution consists of the TM-AutoAcquisition. TM-Worklist. TM-Server. TM-Reception, TM-ReceptionHE, TM-Reception Lite, TM-Home, TM-Link and TM-Publisher.
TM-AutoAcquisition acquires image studies from medical devices, converts them into secure multimedia documents and sends them to the TM-Server. The TM-Worklist is used by the TM-AutoAcquisition to validate patient information. The TM-Server manages documents and security permissions. The TM-Reception allows
1
authenticated users to retrieve, manage, review and process their image documents. The TM-ReceptionHE is an enhanced TM-Reception that provides users with extra image processing features. The TM-Reception Lite allows users to manage and review local image documents. The TM-Home delivers TM-Reception's features for personal use. The TM-Link provides transparent integration between Telemis-Medical and Electronic Patient Record system. The TM-Publisher makes image study summary available on CD-ROM, paper or e-mail.
Intended Use:
The Telemis-Medical solution is a software package intended for the acquisition, management, distribution and display of medical images within the healthcare system. It can be marketed as software only, as well as packaged with standard PC hardware. It was developed with the Java® technology that allows the software to run on every operating system implementing a Java Virtual Machine Environment (f.i. Windows, MacOS, Unix). It communications using the standard TCP/IP network protocol.
Technological comparison to Predicate Device:
The Telemis-Medical solution is substantially equivalent to the Stentor, Inc. iSite Radiology (K013630) system, in that it receives DICOM images, converts them to lossless or lossy (wavelet or jpeq) format, store, transmit and displays them. The intended use and technological characteristics of the Telemis-Medical solution are virtually identical to the Stentor iSite system. Any differences between the Telemis-Medical solution and the equivalent devices have no significant influence on safety or effectiveness.
Conclusion:
It is our conclusion that there is no software component in the Telemis-Medical solution or hardware component that would be used in conjunction with the Telemis-Medical solution 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 Telemis Medical Solution product is "minor".
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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird with three curved lines forming its body and wings. The bird is oriented to the right. Encircling the bird is text that reads 'National Institute for Healthcare Research'.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas J. Bouchard Official Correspondent Telemis-Medical S.A. 7560 Lindberg Drive
GAITHERSBURG MD 20879
Re: K032157
SEP 2 4 2003
Trade/Device Name: Telemis-Medical Solution Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: May 20, 2003 Received: July 14, 2003
Dear Mr. Bouchard:
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
This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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
4
of Page
510(k) Number (if known):
Device Name: Telemis-Medical
Indications For Use:
The Telemis-Medical solution is a software package intended for the acquisition, management, distribution and display of medical images within the healthcare system.
It can be marketed as software only, as well as packaged with standard PC hardware. It was developed with the Java® technology that allows the software to run on every operating system implementing a Java Virtual Machine Environment (f.i. Windows, MacOS, Unix). It communications using the standard TCP/IP network protocol.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
(Optional Format 3-10-98)
David M. Sezmm
(Division Sign-Off) Division of Reproductive. and Radiological Devic 510(k) Number