Sienet Archive Server, Isa I, Isa II Storage Serve
FDA 510(k) K920310 · Siemens Gammasonics, Inc.
Submission
- Device name
- Sienet Archive Server, Isa I, Isa II Storage Serve
- Applicant
- Siemens Gammasonics, Inc.
Hoffman Estates, IL, US - Received
- January 23, 1992
- Decision date
- March 30, 1992
- 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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Questions and answers
When was Sienet Archive Server, Isa I, Isa II Storage Serve cleared by the FDA?
Sienet Archive Server, Isa I, Isa II Storage Serve (K920310) received a 510(k) decision of Substantially Equivalent on March 30, 1992, 67 days after the submission was received.
What is the product code of K920310?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.