Nova Microsonics Access Image Management Network/Access Acquisition Module
FDA 510(k) K940423 · Advanced Technology Laboratories, Inc.
Submission
- Device name
- Nova Microsonics Access Image Management Network/Access Acquisition Module
- Applicant
- Advanced Technology Laboratories, Inc.
Bothell, WA, US - Received
- January 31, 1994
- Decision date
- July 29, 1994
- 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 Nova Microsonics Access Image Management Network/Access Acquisition Module cleared by the FDA?
Nova Microsonics Access Image Management Network/Access Acquisition Module (K940423) received a 510(k) decision of Substantially Equivalent on July 29, 1994, 179 days after the submission was received.
What is the product code of K940423?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.