(78 days)
Dejarnette Teleshare, Line Imaging WinRad, SIENET DRC (Magic View workstation), CompuMed PC Teleradiology product
Not Found
No
The summary describes a teleradiology viewing station for transmitting, viewing, and reporting on medical images, without mentioning any AI or ML capabilities.
No.
The device is described as a viewing station for patient information and images and reporting, fulfilling a diagnostic or informational role rather than directly treating a condition.
No
The device is described as a "viewing station" for "viewing patient information and images and reporting," indicating it assists in the display and transmission of medical data rather than independently diagnosing conditions.
Unknown
The description refers to a "viewing station" which could imply hardware, although the primary function described is software-based viewing and reporting. Without a clearer statement about the device being solely software, it's ambiguous.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue to detect diseases or other conditions.
- Device function: The description clearly states the device is a "viewing station" for "viewing patient information and images and reporting." It focuses on the transmission and display of medical images (teleradiology).
- Lack of mention of biological samples or testing: There is no mention of analyzing biological samples or performing any kind of diagnostic test on them.
The device's function is related to medical imaging and information management, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
This premarket notification covers the LAN and WAN teleradiology concept (transmission), and study information distribution functions. The CompuMed DICOM client is an on-site (LAN) or offsite (WAN or dial up) station for viewing patient information and images and reporting. It supports industry standard information transmission and communication protocols.
Product codes
Not Found
Device Description
The CompuMed DICOM client is a viewing station manufactured by CompuMed, Inc. The CompuMed DICOM client is an on-site (LAN) or offsite (WAN or dial up) station for viewing patient information and images and reporting. It supports industry standard information transmission and communication protocols.
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)
Dejarnette Teleshare, Line Imaging WinRad, SIENET DRC (Magic View workstation), CompuMed PC Teleradiology product
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Attachment J: Glossary
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이용자
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
I. GENERAL INFORMATION
- Establishment: Address: .
- Registration Number:
- . Contact Person:
CompuMed Inc 1200 No El Dorado Place C300 Tucson AZ 85715
2029024
Loren Larsen Manager, Regulatory Submissions 520-544-0544 FAX 520-296-2555
-
Date of Submission Preparation .
Device Name: -
Trade Name: ● Classification:
-
for PACS (Picture Archiving
December 5, 1995
CompuMed DICOM Client No formal classifications have been issued and Communication Systems) or PACS components. For purposes of determining substantial equivalence, they have been considered to be accessories to medical imaging devices.
Performance Standards: .
None established under Section 514 of the Food, Drug, and Cosmetic Act
II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
-
. Device Description and Intended Use: This premarket notification covers the LAN and WAN teleradiology concept (transmission), and study information distribution functions.
The CompuMed DICOM client is a viewing station manufactured by CompuMed, Inc. The CompuMed DICOM client is an on-site (LAN) or offsite (WAN or dial up) station for viewing patient information and images and reporting. It supports industry standard information transmission and communication protocols. -
Technological Characteristics: The LAN and WAN (Teleradiology) products described are DICOM conformant. The CompuMed DICOM client is a low-cost viewing workstation for on-site and off-site viewing and reporting.
-
. General Safety and Effectiveness Concerns: The device labeling contains instructions for use. It includes indications for use and cautions. This information provides for safe and effective use of the device.
-
Substantial Equivalence:
CompuMed DICOM client December 5, 1995 CONFIDENTIAL
510(k) Premarket Notification Page 44
2
The CompuMed DICOM client addressed in this premarket notification, is
substantially equivalent to the following commercially system is and ochparited DICOM client addressed in this premarket notification,
subscription to the following commercially available devices:
- CompuMed PC Teleradiology product .
- Dejarnette Teleshare
- Line Imaging WinRad
- SIENET DRC (Magic View workstation)
The CompuMed DICOM client products have the same intended use and similar
technical characteristics as the devices listed above the occilipanted DICOM client products have the same
company consisteristics as the devices listed above.
Phillip Beuer
Signature
12/12/95
Date
CompuMed DICOM client
December 5, 1995 CONFIDENTIAL