Linx Networking System
FDA 510(k) K964250 · Sterling Diagnostic Imaging, Inc.
510(k) numberK964250
Submission
- Device name
- Linx Networking System
- Applicant
- Sterling Diagnostic Imaging, Inc.
Newark, DE, US - Received
- October 24, 1996
- Decision date
- December 18, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LMD – System, Digital Image Communications, Radiological
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 892.2020
- Specialty
- Radiology
A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. 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…
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| K973206 | Sterling Diagnostic Imaging Direct RadiographyMQB · Traditional | 12/04/1997SE |
| K972660 | Raven Dry PrinterLMC · Traditional | 11/10/1997SE |
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Questions and answers
When was Linx Networking System cleared by the FDA?
Linx Networking System (K964250) received a 510(k) decision of Substantially Equivalent on December 18, 1996, 55 days after the submission was received.
What is the product code of K964250?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.