Securview DX Diagnostic Workstation
FDA 510(k) K103385 · Hologic, Inc.
510(k) numberK103385
Submission
- Device name
- Securview DX Diagnostic Workstation
- Applicant
- Hologic, Inc.
Danbury, CT, US - Received
- November 18, 2010
- Decision date
- February 2, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Securview DX Diagnostic Workstation cleared by the FDA?
Securview DX Diagnostic Workstation (K103385) received a 510(k) decision of Substantially Equivalent on February 2, 2011, 76 days after the submission was received.
What is the product code of K103385?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.