(55 days)
No
The document describes a networking system for connecting image input and output devices, focusing on interfaces, data types, and transfer mechanisms. There is no mention of AI, ML, or any related concepts like algorithms for image analysis or decision support.
No.
The device is described as a networking system that connects image input devices to output devices. It facilitates image transfer and management, but there is no indication that it directly applies treatment or therapy to a patient.
No
The device primarily functions as a networking system for image transfer between input and output devices, rather than performing diagnostic analysis of medical conditions.
No
The device description explicitly mentions "image input devices" and "output devices," implying hardware components are part of the system, not just software. The predicate device also includes a "Laser Imager," further suggesting hardware is involved.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description focuses on connecting image input devices to output devices for image transfer and management. This is related to medical imaging systems and data handling, not the examination of specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description reinforces the concept of a networking system for medical images.
- Lack of IVD-specific information: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
The device appears to be a medical imaging networking and management system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
This Premarket Notification 510(k) is being filed to cover additions to the LINX™ Networking System with LINX™ Laser Imager (K900935) to include all capabilities that we are adding to meet market demands. The basic product concept remains - to connect various image input devices to one or more output devices. That basic concept has been expanded to meet market demands: new image source interfaces new control interfaces new network interfaces more output devices supported new data types managed image transfer mechanisms (some output devices may require handling in the transmission path to the output device to compensate for differences in devices)
Product codes
Not Found
Device Description
The LINX™ Networking System is designed to connect various image input devices to one or more output devices. The expanded version of the system includes new image source interfaces (Video, Digitech-std422, digitizer interface, computed radiography int, removable media, network interfaces, DICOM Devices), new control interfaces, new network interfaces (token-ring, ethernet, ATM, FDDI, TCP/IP, WAN), support for more output devices (home telerad systems, DICOM Devices, File systems), new data types (patient info), and accessory device interfaces (Densitometer, Bar Code Entry). It also manages image transfer mechanisms including straight thru, crop, LUT, sharpness filter, interpolate, decimate, and compress (lossless).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video, Digitech-std422, digitizer interface, computed radiography, removable media, network interfaces, DICOM Devices.
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)
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.
0
Diagnostic Imaging, Inc.
SUMMARY OF SAFETY AND EFFECTIVENESS 510(k)
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.
SUBMITTED BY:
Jean E. Bartlett (302) 451-0282 Regulatory Affairs Sterling Diagnostic Imaging, Inc. Glasgow Business Community Building 600/Mailbox 630 19714-6101 Newark, DE Fax # (302) 451-0386
DEVICE NAME:
LINX™ Networking System
PREDICATE DEVICE:
LINX™ Networking System with LINX™ Laser Imager (K900935)
DEVICE DESCRIPTION AND INTENDED USE:
This Premarket Notification 510(k) is being filed to cover additions to the LINX™ Networking System with LINX™ Laser Imager (K900935) to include all capabilities that we are adding to meet market demands. The basic product concept remains - to connect various image input devices to one or more output devices. That basic concept has been expanded to meet market demands:
new image source interfaces new control interfaces new network interfaces more output devices supported new data types managed image transfer mechanisms (some output devices may require handling in the transmission path to the output device to compensate for differences in devices)
Glasgow Business Community P.O. Box 6101 Building 600, Mailstop 630 Newark, DE 19714 - 6101
1
DEVICE COMPARISON TO PREDICATE DEVICE:
The LINX™ Networking System is substantially equivalent to the LINX™ Networking System with LINX™ Laser Imager (K900935) as summarized below:
| Characteristic | LINX Networking System | LINX Networking System
-(Expanded) |
|----------------------------------------------------------------------------------------------------|--------------------------------------|---------------------------------------|
| Image Sources | | |
| Video | X (up to 45Mhz
pixel clock speed) | X (up to 160Mhz
pixel clock speed) |
| Digitech-std422 | X | X |
| digitizer interface | | X |
| computed radiography int | | X |
| removable media | | X |
| network interfaces | | X |
| DICOM Devices | | X |
| Network connections | | |
| token - ring | X | X |
| ethernet | | X |
| ATM | | X |
| FDDI | | X |
| protocols | | |
| QNX | X | X |
| TCP/IP | | X |
| Interface methods | | |
| point - point | X | X |
| network | X | X |
| LAN | X | X |
| WAN | | X |
| Operator Interfaces | | |
| hardware keypad | X | X |
| Windows | | X |
| remote host | | X |
| Data Types | | |
| image | X | X |
| text | X | X |
| patient info | | X |
| Output devices | | |
| LINX Laser Imager | X | X |
| 3M 952 | X | X |
| 3M 831 | X | X |
| 3M 969 | X | X |
| LP400 | X | X |
| home telerad systems | | X |
| DICOM Devices | | X |
| File systems | | X |
| Characteristic | LINX Networking System | LINX Networking System
(Expanded) |
| Accessory Device Interfaces | | X |
| Densitometer | | X |
| Bar Code Entry | | X |
| Statistics Recording | X | X |
| Image Data | | X |
| Service Data | X | X |
| Image transfer mechanisms | | |
| straight thru
crop
LUT
sharpness filter
interpolate
decimate
compress (lossless) | X
X | X
X
X
X
X
X
X |
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