ASPIRE Cristalle Breast Tomosynthesis System

Digital Breast Tomosynthesis

FDA Premarket Approval P160031 S001

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 the implementation of the synthesized 2d (s-view) image, changing the image processing in dbt reconstruction to iterative super-resolution reconstruction (isr), applying new image processing, dynamic visualization ii for mammography (dviim), to dbt and synthesized 2d images, and related changes in the indications for use (ifu).

DeviceASPIRE Cristalle Breast Tomosynthesis System
Classification NameDigital Breast Tomosynthesis
Generic NameDigital Breast Tomosynthesis
ApplicantFUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Date Received2018-10-23
Decision Date2019-02-08
PMAP160031
SupplementS001
Product CodeOTE
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
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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