Sienet Image Display Workstations, Image Acquisiti
FDA 510(k) K920319 · Siemens Gammasonics, Inc.
510(k) numberK920319
Submission
- Device name
- Sienet Image Display Workstations, Image Acquisiti
- Applicant
- Siemens Gammasonics, Inc.
Hoffman Estates, IL, US - Received
- January 24, 1992
- Decision date
- October 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 Image Display Workstations, Image Acquisiti cleared by the FDA?
Sienet Image Display Workstations, Image Acquisiti (K920319) received a 510(k) decision of Substantially Equivalent on October 20, 1992, 270 days after the submission was received.
What is the product code of K920319?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.