Immerge Image Correlation
FDA 510(k) K970623 · Surgical Navigation Technologies, Inc.
510(k) numberK970623
Submission
- Device name
- Immerge Image Correlation
- Applicant
- Surgical Navigation Technologies, Inc.
Broomfield, CO, US - Received
- February 19, 1997
- Decision date
- April 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Immerge Image Correlation cleared by the FDA?
Immerge Image Correlation (K970623) received a 510(k) decision of Substantially Equivalent on April 28, 1997, 68 days after the submission was received.
What is the product code of K970623?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.