510(k) · Cleared
ClearedACIES
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konica Minolta Medical & Graphic, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 4, 2011 as substantially equivalent to K062107 (Hologic, Inc., 2006) and 1 other predicate after a 218-day review. Its family tree reaches back 6 generations to 1991. 3 later devices descend from it.
- Decided
- Feb 4, 2011
- Review
- 218 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K913770 (1991). 10 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 4 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 3 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 2 generations backK041555 Securview DX Softcopy WorkstationHologic, Inc. · 2004
- 1 generation backK062107 Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and…Hologic, Inc. · 2006
- This deviceK101842 ACIESKonica Minolta Medical & Graphic, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK133730 CO Pilot/Regius UniteaKonica Minolta, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK210066 ImagePilotKonica Minolta, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK240281 Bone Suppression SoftwareKonica Minolta, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −4 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −3 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −2 | K041555 | Securview DX Softcopy Workstation | Hologic, Inc. | 2004 | — |
| −1 | K062107 | Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003 | Hologic, Inc. | 2006 | — |
| 0 (this device) | K101842 | ACIES | Konica Minolta Medical & Graphic, Inc. | 2011 | — |
| +1 | K133730 | CO Pilot/Regius Unitea | Konica Minolta, Inc. | 2014 | — |
| +2 | K210066 | ImagePilot | Konica Minolta, Inc. | 2021 | 1 |
| +3 | K240281 | Bone Suppression Software | Konica Minolta, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062107 | Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003Summary page 1…tem 6. Classification Class 11 , 21 CFR 892. 2050, Picture Archiving and Communications System 7. Product Code 90 LLZ 8. Predicate Device HOLOGIC Securiew DX, K062107 KONICAMINOLTA REGIUS Unitea / ImagePilot, K071436 9. Description of Device The Acies is the software that is intended to con… | 2006 |
| * | K071436 | Regius UniteaSummary page 1…, Picture Archiving and Communications System 7. Product Code 90 LLZ 8. Predicate Device HOLOGIC Securiew DX, K062107 KONICAMINOLTA REGIUS Unitea / ImagePilot, K071436 9. Description of Device The Acies is the software that is intended to configure PACS (Picture Archiving and Communications… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133730 | CO Pilot/Regius Unitea | 2014 | 2 |
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 20 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K133730 (Konica Minolta, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K062107.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Acies is a software product. It is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The Acies primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The Acies can process and display medical images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or…
Read the full statement (111 words)
The Acies is a software product. It is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The Acies primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The Acies can process and display medical images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards.
Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101842: ACIES.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101842
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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