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ASPIRE Cristalle Digital Breast Tomosynthesis Option

by Fujifilm Medical Systems U.S.A, Inc.

PMA P160031510(k) K173132

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

1 ongoing

Recall on shared PMA P160031; other models may be affected

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK173132 Date27 Oct 2017IssuedStatusActive
United StatesFDA PMA PMA NumberP160031 Date10 Jan 2017ApprovedStatusActive

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-2219-2025 FDA Class II initiated 11 Jun 2025 on shared PMA P160031

    Devices had an unapproved slabbing software function enabled for use.

    • Terminated Z-0661-2018 FDA Class II initiated 4 Aug 2017

    FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.

    • Terminated Z-0386-2018 FDA Class II initiated 14 Jul 2017

    There was a case that the swivel arm went down unintentionally when it was moved up/down.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k), FDA PMA Active

Specification

510(k) · PMA

Full name
ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option
Trade Name
Aspire Cristalle Digital Breast Tomosynthesis Option
Generic Name
Digital breast tomosynthesis
PMA Number
510(k) Number
FDA Product Code
MUE
Device Class
Class II
Regulation
21 CFR Part 892.1715
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option is a medical imaging system designed to acquire and generate both Full Field Digital Mammography (FFDM) and DBT images. It is intended for use in the clinical screening and diagnosis of breast cancer, providing clinicians with detailed image sets to support diagnostic accuracy.

Examinations may be performed using FFDM mode alone, or by combining FFDM and DBT image sets acquired in standard mode. These images are captured using N-mode dose settings and can be obtained through either a single compression or separate compressions depending on the selected mode. This device is manufactured by Fujifilm Medical Systems U.S.A, Inc. and holds FDA authorization.

Other devices from Fujifilm Medical System U.S.A., Inc.

See all devices from Fujifilm Medical System U.S.A., Inc. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the ASPIRE Cristalle DBT Option?

    The device is intended for use in the screening and diagnosis of breast cancer by acquiring and generating both Full Field Digital Mammography and Digital Breast Tomosynthesis images.

  • How are images acquired with this system?

    Images are acquired using N-mode dose settings. Depending on the clinical requirements, the system can capture image sets in a single compression or through separate compressions for FFDM and DBT modes.

  • Does this system support standard mammography?

    Yes, the system supports Full Field Digital Mammography (FFDM) either as a standalone screening mode or in combination with a DBT image set acquired in standard mode.