Aspire Cristalle Digital Breast Tomosynthesis Option

Digital Breast Tomosynthesis

FDA Premarket Approval P160031 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for changing the image processing in dbt reconstruction to iterative super-resolution reconstruction (isr) and applying new image processing, dynamic visualization ii for mammography (dviim), to the dbt and the ffdm images.

• Device: Aspire Cristalle Digital Breast Tomosynthesis Option
• Classification Name: Digital Breast Tomosynthesis
• Generic Name: Digital Breast Tomosynthesis
• Applicant: FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
• Date Received: 2019-04-29
• Decision Date: 2019-10-25
• PMA: P160031
• Supplement: S002
• Product Code: OTE
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 West Avenue stamford, CT 06902-6300

Supplemental Filings

Supplement Number	Date	Supplement Type
P160031		Original Filing
S003	2020-07-02	Real-time Process
S002	2019-04-29	Normal 180 Day Track
S001	2018-10-23	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
04547410351316	P160031	000