Dicom Theater
FDA 510(k) K033153 · Ferguson Medical
510(k) numberK033153
Submission
- Device name
- Dicom Theater
- Applicant
- Ferguson Medical
Albuquerque, NM, US - Received
- September 30, 2003
- Decision date
- April 23, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Dicom Theater cleared by the FDA?
Dicom Theater (K033153) received a 510(k) decision of Substantially Equivalent on April 23, 2004, 206 days after the submission was received.
What is the product code of K033153?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.