FDR Aqro (Dr-Xd 1000)
FDA 510(k) K170858 · Fujifilm Medical Systems U.S.A, Inc.
510(k) numberK170858
Submission
- Device name
- FDR Aqro (Dr-Xd 1000)
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
Stamford, CT, US - Received
- March 22, 2017
- Decision date
- April 24, 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 FDR Aqro (Dr-Xd 1000) cleared by the FDA?
FDR Aqro (Dr-Xd 1000) (K170858) received a 510(k) decision of Substantially Equivalent on April 24, 2017, 33 days after the submission was received.
What is the product code of K170858?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.