Digital Imaging System
FDA 510(k) K954159 · Camtronics, Ltd.
510(k) numberK954159
Submission
- Device name
- Digital Imaging System
- Applicant
- Camtronics, Ltd.
Hartland, WI, US - Received
- September 5, 1995
- Decision date
- March 19, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Digital Imaging System cleared by the FDA?
Digital Imaging System (K954159) received a 510(k) decision of Substantially Equivalent on March 19, 1996, 196 days after the submission was received.
What is the product code of K954159?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.