Registration and Fusion
FDA 510(k) K080013 · Agfa Healthcare Corporation
510(k) numberK080013
Submission
- Device name
- Registration and Fusion
- Applicant
- Agfa Healthcare Corporation
Greenville, SC, US - Received
- January 3, 2008
- Decision date
- January 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K071972 | Orthopedic Software for Impax WorkstationsLLZ · Traditional | 07/30/2007SE |
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Questions and answers
When was Registration and Fusion cleared by the FDA?
Registration and Fusion (K080013) received a 510(k) decision of Substantially Equivalent on January 17, 2008, 14 days after the submission was received.
What is the product code of K080013?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.