ASPIRE Bellus II
FDA 510(k) K171463 · Fujifilm Medical Systems U.S.A, Inc.
510(k) numberK171463
Submission
- Device name
- ASPIRE Bellus II
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
Stamford, CT, US - Received
- May 18, 2017
- Decision date
- September 29, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ASPIRE Bellus II cleared by the FDA?
ASPIRE Bellus II (K171463) received a 510(k) decision of Substantially Equivalent on September 29, 2017, 134 days after the submission was received.
What is the product code of K171463?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.