ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option

FDA Premarket Approval P160031 S003

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 1) the integration of the dbt option as a software module on the 510(k) cleared aspire bellus ii (k171463) for the reconstruction of tomosynthesis acquisitions, and 2) an updated indications for use to include the optional integration of the dbt option software module on the cleared aspire bellus ii and its functionality.

DeviceASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option
Generic NameDigital Breast Tomosynthesis
ApplicantFUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Date Received2020-07-02
Decision Date2020-09-30
PMAP160031
SupplementS003
Product CodeOTE 
Advisory CommitteeRadiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 West Avenue stamford, CT 06902-6300

Supplemental Filings

Supplement NumberDateSupplement Type
P160031Original 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 IDPMASupp
04547410351316 P160031 000
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