ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR

Full Field Digital, System, X-ray, Mammographic

FUJIFILM MEDICAL SYSTEM U.S.A., INC.

The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Aspire Cr For Mammography System (crm); Fcr Aspire Crn (reader). Note For General Radiography, Reader Is Carbon Xl2/fcr.

Pre-market Notification Details

• Device ID: K111646
• 510k Number: K111646
• Device Name: ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR
• Classification: Full Field Digital, System, X-ray, Mammographic
• Applicant: FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300
• Contact: Debbie Peacock
• Correspondent: Debbie Peacock; FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300
• Product Code: MUE
• CFR Regulation Number: 892.1715 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-13
• Decision Date: 2011-12-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04547410250459	K111646	000
04547410250442	K111646	000