Digital Imaging System Interface
FDA 510(k) K953080 · Camtronics, Ltd.
510(k) numberK953080
Submission
- Device name
- Digital Imaging System Interface
- Applicant
- Camtronics, Ltd.
Hartland, WI, US - Received
- July 3, 1995
- Decision date
- September 28, 1995
- 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 Digital Imaging System Interface cleared by the FDA?
Digital Imaging System Interface (K953080) received a 510(k) decision of Substantially Equivalent on September 28, 1995, 87 days after the submission was received.
What is the product code of K953080?
The FDA product code is LMD – System, Digital Image Communications, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2020.