510(k) Report

510(k) · Cleared

Cleared

Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader). Note for General Radiography, Reader IS Carbon XL2/FCR

K111646510(k) TraditionalCleared Dec 8, 2011178-day reviewClass II21 CFR 892.1715

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fujifilm Medical System U.S.A., Inc. · MUE Full Field Digital, System, X-Ray, Mammographic

Cleared on Dec 8, 2011 as substantially equivalent to P080018 (Carestream Health, Inc., 2010) after a 178-day review. Its family tree reaches back 1 generation to 2010.

Decided
Dec 8, 2011
Review
178 days
Class
Class II
Product code
MUE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to P080018 (2010). No later device cites it as a predicate yet.

P080018 · Kodak Directview Computed Radiography (CR) Mammography · Carestream Health, Inc. · 2010 · recalled20102012
P080018 · Kodak Directview Computed Radiography (CR) Mammography · Carestream Health, Inc. · 2010 · recalled0
  1. Root · 1 generation backP080018 Kodak Directview Computed Radiography (CR) MammographyCarestream Health, Inc. · 2010 · Recalled
  2. This deviceK111646 Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader).…Fujifilm Medical System U.S.A., Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P080018Kodak Directview Computed Radiography (CR) MammographyCarestream Health, Inc.20101
0 (this device)K111646Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader). Note for…Fujifilm Medical System U.S.A., Inc.2011—
FIG. 1 — Lineage of K111646, 2010–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MUE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MUE device

  1. #1 K253678 MAMMOMAT B.brilliant (11372950)score 13.6 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*P080018Kodak Directview Computed Radiography (CR) Mammography
Summary page 5
…mammographic usage. 5. SUBSTANTIAL EQUIVALENCE The Aspire CRm FFDM System is substantially equivalent to the predicate device, Kodak DirectView CR Mammography System (P080018) and our own Fuji CR for Mammography System (FCRMS). The Aspire CRm uses the same acquisition workstation as our currently approv…
Carestream Health, Inc.20101
*—Fuji CR for Mammography System (FCRMS)
Named without a submission number
—

Also cleared against P080018: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • 1 other device also cites its predicate P080018.

How does its category compare?

All MUE devices

MUE Full Field Digital, System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MUE

3in 2025

2007: 62008: 52009: 82010: 102011: 102012: 42013: 72014: 12015: 12016: 12017: 82018: 22019: 22020: 42021: 42022: 32023: 12024: 12025: 32026 (partial year): 4
2007high 10 (2010) · low 1 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUE

255in 2025

2011: 192 days median2012: 123 days median2013: 207 days median2017: 95 days median2020: 188 days median2021: 164 days median2022: 404 days median2025: 255 days median2026 (partial year): 185 days median
2007high 404 (2022) · low 95 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUE

4in 2025

2008: 12009: 12010: 22011: 52014: 22017: 62018: 12019: 12023: 12025: 42026 (partial year): 1
2007high 6 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MUE

40in 2025

2008: 42009: 32010: 22011: 102012: 62013: 112014: 72015: 62016: 192017: 1152018: 1452019: 802020: 492021: 252022: 362023: 292024: 332025: 40
2007high 145 (2018) · low 0 (2007)2025

MAUDE reports naming product code MUE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076—00
20085—14
20098—13
201010—22
201110192510
2012412306
20137207011
20141—27
20151—06
20161—019
20178956115
20182—1145
20192—180
20204188049
20214164025
20223404036
20231—129
20241—033
20253255440
202641851—

What is it indicated for?

The Aspire CR for Mammography (GRin) System is indicated for generating mamnmographic images that can be used for screening and diagnosis of breast cancer. The Fuji Aspire GRin System is intended to be used in the same clinical applications as traditional film/screen systems.

Indications for use as stated in the FDA summary.

Also cleared against P080018

1 other device cites the same predicate.

  • K120246Kodak Directview CR Mammography System (Using Carestream CR Mammography Cassette with SNP-M1 Screen)Carestream Health, Inc. · 2012

More from Fujifilm Medical System U.S.A., Inc.

74 FDA decisions under this applicant name. See the company

  • K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
  • K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. · 2016
  • K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. · 2016
  • K152138FDR D-EVO GL Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc. · 2015
  • K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc. · 2015

Recent decisions in MUE

The MUE category page

  • K254090I-View®Hologic, Inc. · 2026
  • K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc. · 2026
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https://510kreport.com/device/K111646 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111646: Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader). Note for General Radiography, Reader IS Carbon XL2/FCR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111646

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026