# K110729: Aspire HD Full-Field Digital Mammography System

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Sep 1, 2011 after 169 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P030010 (2004). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P030010: Siemens Mammomat Novationdr Full Field Digital Mammography System, Siemens Medical Solution (2004) Summary page 1.
- P030010/S006: Siemens Mammomat Inspiration Full - Field Digital Mammography System, Siemens Medical Solution (2010) Summary page 1.

## Most influential descendants
- K121674: Aspire HD Plus, Aspire HD-S (2012), 4 descendants of its own
- K133972: Aspire Cristalle (2014), 3 descendants of its own
- K173132: ASPIRE Cristalle (2017), 2 descendants of its own
- K212873: Aspire Cristalle (2022), 1 descendant of its own
- K243420: Hestia (2025), 0 descendants of its own

## Recalls of this device
- Aug 4, 2017 · Class II · Z-0659-2018: 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 uni
- Jun 9, 2016 · Class II · Z-2690-2016: If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
- Feb 3, 2015 · Class II · Z-1585-2015: User Manual lacks a description for handling some errors even though the system can be recovered from such errors

## Indications for use
The Fujifilm Digital Mammography System, Aspire HD (FOR MS-i 000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.

Source page: https://510kreport.com/device/K110729
Methodology: https://510kreport.com/methodology