Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader). Note for General Radiography, Reader Is Carbon XL2/FCR
FDA 510(k) K111646 · Fujifilm Medical System U.S.A., Inc.
510(k) numberK111646
Submission
- Device name
- Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader). Note for General Radiography, Reader Is Carbon XL2/FCR
- Applicant
- Fujifilm Medical System U.S.A., Inc.
Stamford, CT, US - Received
- June 13, 2011
- Decision date
- December 8, 2011
- 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 CR for Mammography System (CRM); FCR Aspire CRN (Reader). Note for General Radiography, Reader Is Carbon XL2/FCR cleared by the FDA?
Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader). Note for General Radiography, Reader Is Carbon XL2/FCR (K111646) received a 510(k) decision of Substantially Equivalent on December 8, 2011, 178 days after the submission was received.
What is the product code of K111646?
The FDA product code is MUE – Full Field Digital, System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1715.