(156 days)
Not Found
No
The summary describes a standard medical image viewing and management system with no mention of AI or ML capabilities.
No
The device is described as an "image Viewing Station" used to "Acquire, store, transmit, and display medical images and patient reports". It supports image distribution and report writing, but does not directly provide therapy or affect a patient's health outcome.
No
The device is described as an image viewing station that displays, stores, and transmits medical images and reports, and supports radiologists in writing reports. It does not mention any function for interpreting or analyzing medical images to diagnose conditions.
No
The device description mentions "Video Input (NTSC video input signals)", which implies the device can accept hardware video input, suggesting it is not purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on acquiring, storing, transmitting, and displaying medical images and patient reports. This is related to medical imaging interpretation, not the analysis of biological samples or specimens to provide diagnostic information about a patient's health status.
- Device Description: The description highlights image viewing, distribution, archiving, and reporting for medical images. It doesn't mention any functionality related to analyzing biological samples or performing tests on them.
- Input: The inputs are DICOM files and video signals, which are image data, not biological samples.
- No mention of biological sample analysis: There is no indication in the provided text that the device interacts with or analyzes any biological materials (blood, urine, tissue, etc.).
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is centered around the management and viewing of medical images, which falls under the category of medical imaging devices or PACS (Picture Archiving and Communication Systems) components.
N/A
Intended Use / Indications for Use
Acquire, store, transmit, and display medical images and patient reports of various types. Teleradiology image acquisition, distribution, archive and viewing.
Product codes (comma separated list FDA assigned to the subject device)
90-LMD, 90-LLZ
Device Description
The IiVS™ Integrated image Viewing Station is a product family, which comes in two different versions:
DiVS: a DICOM viewer liVS: a 3D viewer
The intended use of the devices is to provide solutions to various medical image-viewing problems, which come about as the modalities generate more and more images. They also support image distribution over networks, and are DICOM conformant.
Finally, the IIVS™ Integrated image Viewing Station family supports the radiologist in writing a report, and transmitting and storing this report in digital form.
Mentions image processing
Not Found
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
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
§ 892.2020 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.
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K994329
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Device Name:
Trade Name: Common Name: Classification Name: Teleradiology System DIVS & IiVS™ Integrated image Viewing Stations Image communication and storage system System, Digital Image Communication
Establishment Name & Registration Number:
Name: TeraRecon, Inc. Number: Pending
Classification:
Title 21, Code of Federal Regulations, § 892.2020 & § 892.2050. Now proposed exempt, final rule pending.
90-LMD & 90-LLZ ProCode:
Equivalent Device(s):
Acculmage™ Viewer Products, K961023, by Acculmage, Inc.
The referenced systems are equivalent to the DVS and IiVS™ Integrated image Viewing Stations in terms of basic design, features and intended use.
Description of the Device:
The IiVS™ Integrated image Viewing Station is a product family, which comes in two different versions:
DiVS: a DICOM viewer liVS: a 3D viewer
The intended use of the devices is to provide solutions to various medical image-viewing problems, which come about as the modalities generate more and more images. They also support image distribution over networks, and are DICOM conformant.
Finally, the IIVS™ Integrated image Viewing Station family supports the radiologist in writing a report, and transmitting and storing this report in digital form.
Applicant / Sponsor Name / Address:
TeraRecon, Inc. 2955 Campus Drive, Suite 325 San Mateo, CA 94403 650.372.2669
Contact Person:
Horst Brüning, Ph.D. VP Engineering TeraRecon, Inc. 2955 Campus Drive, Suite 325 San Mateo, CA 94403 650.372.2669
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K994329
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Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 / 925.356.2654 FAX
Manufacturing Facility:
Manadalanting I dolling.
At the present time, the DVS & IiVS™ Integrated image Viewing Station is manufactured by TeraRecon, Inc.
Performance Standards:
There are no applicable FDA mandated performance standards for this device. However, voluntary standards such as DICOM, various in-house Standard Operating Procedures and vendor qualification procedures are in place and utilized in the production of the software.
The software designed to control and manipulate the diagnostic images follows the international standard ISO/IEC 12207: 1995 Informatin technology - Software Life Cycle Processes. In accordance with that standard, the level of concern relative to this software has been determined using the decision tree provided in Version 1 of the FDA Software Guidance.
Hardware requirements
The DiVS will execute on Silicon Graphics SGI-320 and 540 workstations under Windows NT4.0. Memory requirements are 640 MB.
User interface
The user interacts with the system through a standard keyboard and a wheel-mouse. All buttons are marked with commonly understood symbols or English language notation.
Data input:
DTCOM file transfer: Compliance with DICOM 3 Query and Retrieve Max. file size: 512 MB or 1000 slices
Video Input: NTSC video input signals at 30 frames per second. Data output: Data output is user defined and is one of 3 options:
-
- DICOM file
-
- JPEG compressed image file
-
- BMP file
Video output:
NTSC-compatible video output as an option.
The Report Function
Provide preset image format for included images. This format has to be easily modified. Overlay of figures and characters on top of the images to annotate findings. Provide for placing the report on a network as DICOM files or BMP or JPEG format. Provide a print function.
Hardware Information:
The liVS will execute on Silicon Graphics Visual Workstations VW 320 or VW 540. The following configuration is used:
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K 994329
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VW 320
Silicon Graphics 320 Base Model Dual Pentium 111 500 MHz 640 MB of SDRAM 14.4.GB hard disc 32x CD-ROM Silicon Graphics 1600 SW flat panel monitor MS IntelliMouse with wheel USB keyboard
VW 540
Silicon Graphics 540 Base Model Quad Pentium III Xeon 550 MHz 640 MB of SDRAM 9.1 GB Ultra 2 SCSI hard disc e.-h. same as model 320
Comparison Table:
| FEATURE | DIVS & liVS™ | Acculmage™ | SE
? |
|-----------------------------|-------------------------------------------------------------------------------|------------------------------------------------------|---------|
| Intended Use: | Teleradiology image acquisition,
distribution, archival and 3D
viewing. | SAME | Yes |
| Network
Connectivity: | Ethernet 100 Base T | General Purpose Interface
Protocol - GPIB IEEE488 | Yes |
| Computer
Platform: | SGI VW-320 and -540 | PC | Yes |
| Lossy Image
Compression: | JPEG | BMP | Yes |
| DICOM
Compliant: | YES | YES | Yes |
| Image Display: | Color, Grey scale, 1600x1200 | Color, Grey scale, 512x512 | Yes |
| Image Edit: | 8 object segmentation clipping
planes in double oblique
orientation | Manual and threshold
segmentation | Yes |
| Volume
Rendering: | Voxel transmission, parallel and
perspective ray casting | MIP, Surface rendering, Depth
encoded surface, | Yes |
| 2D/3D
Integration: | Automatic display of orthogonal
planes | Display of basic 2D views | Yes |
| Operating
System: | SGI320 , SGI-540 Windows NT | Win95/Win98 | Yes |
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2000
Terarecon, Inc. c/o David W. Schlerf Buckman Company, Inc. 200 Gregory Lane Suite C-100 Pleasant Hill, CA 94523 Re:
K994329 IiVS™ Integrated Image Viewing Station Dated: April 14, 2000 Received: May 1, 2000 Regulatory class: II 21 CFR 892.2050/Procode: 90 LMD/90 LLZ
Dear Mr. Schlerf:
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 uevice is Substantally Quirient (10 the Medical Device Amendment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmelic 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 manked the done, valier of the general post post manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
lf your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to n your dovice a controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Starraditional online. Externination assumes compliance with the Current Good Manufacturing Proclice 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 submission does not affect any obligation you might the reductions 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 r rios to the new 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 and additionally 809.10 for in vito diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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 entitiled, "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/dsma/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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K994321 510(k) Number (if known):_
IiVS™ Integrated image Viewing Station Device Name:
Indications For Use:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Acquire, store, transmit, and display medical images and patient reports of various types. Teleradiology image acquisition, distribution, archive and viewing.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
| Prescription Use | |
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| (Per 21 CFR 801.109) |
Over-The-Counter Use J (Optional format 1-2-96)
David A. Seymore
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
IiVS.doc