510(k) · Cleared
ClearedBone Suppression Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konica Minolta, Inc. · LLZ System, Image Processing, Radiological
Cleared on May 31, 2024 as substantially equivalent to K210066 (Konica Minolta, Inc., 2021) after a 120-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- May 31, 2024
- Review
- 120 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K913770 (1991). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations between
- 3 generations backK101842 ACIESKonica Minolta Medical & Graphic, Inc. · 2011
- 2 generations backK133730 CO Pilot/Regius UniteaKonica Minolta, Inc. · 2014
- 1 generation backK210066 ImagePilotKonica Minolta, Inc. · 2021 · Recalled
- This deviceK240281 Bone Suppression SoftwareKonica Minolta, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 7 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 6 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 5 generations backK041555 Securview DX Softcopy WorkstationHologic, Inc. · 2004
- 4 generations backK062107 Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and…Hologic, Inc. · 2006
- 3 generations backK101842 ACIESKonica Minolta Medical & Graphic, Inc. · 2011
- 2 generations backK133730 CO Pilot/Regius UniteaKonica Minolta, Inc. · 2014
- 1 generation backK210066 ImagePilotKonica Minolta, Inc. · 2021 · Recalled
- This deviceK240281 Bone Suppression SoftwareKonica Minolta, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −8 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −7 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −6 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −5 | K041555 | Securview DX Softcopy Workstation | Hologic, Inc. | 2004 | — |
| −4 | K062107 | Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003 | Hologic, Inc. | 2006 | — |
| −3 | K101842 | ACIES | Konica Minolta Medical & Graphic, Inc. | 2011 | — |
| −2 | K133730 | CO Pilot/Regius Unitea | Konica Minolta, Inc. | 2014 | — |
| −1 | K210066 | ImagePilot | Konica Minolta, Inc. | 2021 | 1 |
| 0 (this device) | K240281 | Bone Suppression Software | Konica Minolta, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K210066 | ImagePilotSummary page 4…(21 CFR 892.2050) Regulatory Class: Class II Product Code: LLZ III. PREDICATE DEVICES Predicate Device: ImagePilot, K210066 Reference Device: Bone Suppression Software, K133442 IV. DEVICE DESCRIPTION The purpose of this software is to provide… | 2021 |
| † | K133442 | Bone Suppression Software | 2014 |
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 33 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 5 of the 17 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Bone Suppression Software is an image processing technology to improve the visibility of soft tissues in the lung area by suppressing the signals of ribs and clavicles in chest x-ray images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240281: Bone Suppression Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240281
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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