Calysto Image Iv-Image and Information Management System
FDA 510(k) K040195 · Witt Biomedical Corp
510(k) numberK040195
Submission
- Device name
- Calysto Image Iv-Image and Information Management System
- Applicant
- Witt Biomedical Corp
Melbourne, FL, US - Received
- January 28, 2004
- Decision date
- April 7, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Calysto Image Iv-Image and Information Management System cleared by the FDA?
Calysto Image Iv-Image and Information Management System (K040195) received a 510(k) decision of Substantially Equivalent on April 7, 2004, 70 days after the submission was received.
What is the product code of K040195?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.