(149 days)
Not Found
No
The description focuses on standard image acquisition, viewing, storage, and transmission using DICOM, with no mention of AI, ML, or advanced image analysis beyond basic processing.
No
The device is a general-purpose software for image acquisition, viewing, and transmission, not a therapeutic device.
No
The device is described as a "general purpose software designed for the acquisition/capture/view/archival and transmission of medical images." It is used for handling and displaying images from various sources, but there is no indication that it analyzes or interprets these images to provide a diagnosis or aid in diagnosis. It's a teleradiology system, which facilitates the viewing and transmission of images, not their diagnostic interpretation.
Yes
The device description explicitly states it is "general purpose software" that operates on "off the shelf" hardware. It focuses on the software's functions (acquisition, capture, view, archival, transmission, processing, display) and communication standards (DICOM), without describing any proprietary or specific hardware components included as part of the device itself.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The T.I.M.S. system is described as a general-purpose software for acquiring, viewing, storing, transmitting, and processing medical images. It handles image data from various imaging modalities (CT, MR, US, etc.).
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples. The device operates solely on image data.
- Focus on Image Management: The core function is managing and displaying medical images for diagnostic interpretation by medical professionals.
Therefore, the T.I.M.S. system falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS) component, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
T.I.M.S. receives image data, acquired from various sources, including but not limited to CT, MR, US, Nuclear, digital angiography and flourography, secondary capture devices (frame grabbers), scanners or other imaging sources. Images and data can be stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the world wide web.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The T.I.M.S. Teleradiology system is a general purpose software designed for the acquisition/capture/view/archival and transmission of medical images. The software operates on "off the shelf" hardware using a Windows 95 or higher platform. It is designed to capture, acquire, send, receive, archive and display patient images and data, using the DICOM communication standard. T.I.M.S. can be installed on a PC in the hospital, via a web-browser, and on a local LAN or WAN, and includes teleradiology, connectivity and display features. It employs the latest internet security techniques, including 128 bit encryption.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, US, Nuclear, digital angiography and flourography, secondary capture devices (frame grabbers), scanners or other imaging sources.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals, physician or trained medical personnel
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
NOV 2 2 2000
Total Medical Information Management Systems, Inc. 407 Wekiva Springs Rd. Suite 347 Longwood, Florida 32779 407-788-6353
K001947
page 1 of 3
510 (k) Summary
-
- Identification
Date Prepared:
- Identification
June 1, 2000
Submitter:
Total Medical Information Management Sys., Inc 407 Wekiva Springs Rd. Suite 347 Longwood, Fl. 32779-6097
Contact:
Don Beavers, President Phone: 407-788-6353 Fax: 407-788-2476
2: Device Name
Proprietary Name: T.I.M.S.
Common Name: Teleradiology System
Classification Name:
Picture Archiving and Communication System
3: Regulatory Class
Class: Panel: Product Code: 2 Radiology CFR 892.2050; LLZ
- Predicate Device
Olicon 02 Workstation and/or PACSVIEW software; K973959 Images-On-Call Teleradiology System; K896095
1
-
- Device Description
K 001947
Page 2 of 3
- Device Description
The T.I.M.S. Teleradiology system is a general purpose software designed for the acquisition/capture/view/archival and transmission of medical images. The software operates on "off the shelf" hardware using a Windows 95 or higher platform. It is designed to capture, acquire, send, receive, archive and display patient images and data, using the DICOM communication standard. T.I.M.S. can be installed on a PC in the hospital, via a web-browser, and on a local LAN or WAN, and includes teleradiology, connectivity and display features. It employs the latest internet security techniques, including 128 bit encryption.
-
- Indications for Use
T.I.M.S. receives image data, acquired from various sources, including but not limited to CT, MR, US, Nuclear, digital angiography and flourography, secondary capture devices (frame grabbers), scanners or other imaging sources. Images and data can be stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the world wide web.
- Indications for Use
-
- Substantial Equivalence Comparison
T.I.M.S. is a medical imaging software device that is substantially equivalent to medical image software devices previously cleared and marketed under the names of Olicon 02-Workstation and/or PACSView software (K973959) and Images-On-Call teleragiology system (K896095). The predicate devices have the same intended use for the receipt of images and data from imaging modalities, secondary capture devices, scanners or imaging gateways. This device does not offer any new functions that have not received previous clearance from the Agency.
- Substantial Equivalence Comparison
-
- Safety and Effectiveness
T.I.M.S. software system is primarily used to capture/view/archive/transmit medical images. It does not require specialized or nonstandard devices of any type. Image acquisition and display is via the industry-standard DICOM 3 protocol, allowing the images to be produced the data originated by the imaging modality, either digital or analog. The software will operate on standard "off the shelt" hardware and system configurations. Similar to predicate devices it can be used with image compression. The lossy/lossless image compression libraries are believed to be substantially equivalent to the libraries used in previously cleared devises.
- Safety and Effectiveness
2
Koo 1947
Page 3 of 3
The software is intended to provide the means for medical professionals to I is soll ware generated by medical scanning devices on a personal computer or workstation.
9. Conclusion
Similar to predicate devices, the T.I.M.S. system software does not contact the patient, or control any life sustaining devices. Images and information being reviewed, processed, relayed, and or transmitted are interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention. In device failures which might result in partial or failed transmissions, the images and or data may be recovered by re-transmission after correcting the problems. Passwords are required for operation and to protect against unauthorized use of the system.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 22 2000
Don Beavers President Total Medical Information Management Systems, Inc. 407 Wekiva Spring Rd., Suite 347 Longwood, FL 32779-6907
Re:
K001947 T.I.M.S. Version 2.00 Dated: October 2, 2000 Received: October 3, 2000 Regulatory class: II 21 CFR 892.2050/Procode: 90LLZ
Dear Mr. Beavers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
4
Page 1 of 1
510 (k) NUMBER (IF KNOWN): K001947
DEVICE NAME: T.I.M.S. TELERADIOLOGY SYSTEM
INDICATIONS FOR USE:
T.I.M.S. receives image data, acquired from various sources, including but not limited to 1.7.M.B. 1000.vos mage digital angiography and flourography, secondary capture devices (frame grabbers), scanners (digitizers) or other imaging sources. Images and data can be viewed, stored, transmitted (communicated), processed at the workstation, physician's vicwou, or other clinical application and distributed across networks or the world wide web for viewing.
(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
(Optional Format 1-2-96) |
| -- | -------------------------------------------------- |
|---|
David A. Leggion
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices510(k) Number _