510(k) · Cleared
ClearedMammography Viewer SMV658
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 25, 2013 as substantially equivalent to K081630 (Image Diagnost International GmbH, 2008) after a 102-day review. Its family tree reaches back 7 generations to 1984.
- Decided
- Oct 25, 2013
- Review
- 102 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K842308 (1984). 30 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 6 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 5 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 4 generations backK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
- 3 generations backK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
- 2 generations backK063628 Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions · 2006 · Recalled
- 1 generation backK081630 Mammo WorkstationImage Diagnost International GmbH · 2008
- This deviceK132188 Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −6 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −5 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −4 | K023100 | Accusketch Cardiac Quantitative System W/ Advanced Analysis Components | General Electric Medical Systems Information Techn | 2002 | — |
| −3 | K042525 | Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital… | Ge Medical Systems Information Technologies | 2004 | 3 |
| −2 | K063628 | Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy | Ge Healthcare Integrated IT Solutions | 2006 | 3 |
| −1 | K081630 | Mammo Workstation | Image Diagnost International GmbH | 2008 | — |
| 0 (this device) | K132188 | Mammography Viewer SMV658 | Fujifilm Medical System U.S.A., Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081630 | Mammo WorkstationSummary page 2…Information (Tele phone Hold) Page 282 of 1158 FUJIFILM Medical Systems U.S.A., Inc. SMV658 V3.0 510O(k) Predicate Device: IMammaWorkstation (K081630). Image Diagnostic International GmbH Description of the Device FUJIFILM's Mammography Viewer SMV658 (V3.0) system receives mamm… | 2008 |
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?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 11 of the 30 ancestors have a recall of any class.
- 1 other device also cites its predicate K081630.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
ASPIRE Bellus is intended to receive digital mammography images and to display these images on monitors for radiologists' review for diagnostic and screening purposes. To assist radiologists, ASPIRE Bellus provides functions such as image review, measurement, post-processing, film printing, displaying mammography CAD results, and image manipulation. ASPIRE Bellus does not accept lossy compressed mammographic images, which should not be used for primary…
Read the full statement (107 words)
ASPIRE Bellus is intended to receive digital mammography images and to display these images on monitors for radiologists' review for diagnostic and screening purposes.
To assist radiologists, ASPIRE Bellus provides functions such as image review, measurement, post-processing, film printing, displaying mammography CAD results, and image manipulation.
ASPIRE Bellus does not accept lossy compressed mammographic images, which should not be used for primary diagnostic interpretation. Display monitors connected to ASPIRE Bellus for diagnostic interpretation of mammographic images must be cleared for use in digital mammography. All images sent to or imported into the ASPIRE Bellus must conform to regulatory requirements. Image quality must conform to applicable quality guidelines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132188 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132188: Mammography Viewer SMV658.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132188
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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