Sienet Diagnostic Reporting Console
FDA 510(k) K920309 · Siemens Gammasonics, Inc.
510(k) numberK920309
Submission
- Device name
- Sienet Diagnostic Reporting Console
- Applicant
- Siemens Gammasonics, Inc.
Hoffman Estates, IL, US - Received
- January 23, 1992
- Decision date
- March 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Sienet Diagnostic Reporting Console cleared by the FDA?
Sienet Diagnostic Reporting Console (K920309) received a 510(k) decision of Substantially Equivalent on March 20, 1992, 57 days after the submission was received.
What is the product code of K920309?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.