510(k) · Cleared
ClearedCO Pilot/Regius Unitea
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 Jan 31, 2014 as substantially equivalent to K071436 (Konica Minolta Medical & Graphic, Inc., 2007) and 2 other predicates after a 56-day review. Its family tree reaches back 7 generations to 1991. 2 later devices descend from it.
- Decided
- Jan 31, 2014
- Review
- 56 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K913770 (1991). 15 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 5 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 4 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 3 generations backK041555 Securview DX Softcopy WorkstationHologic, Inc. · 2004
- 2 generations backK062107 Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and…Hologic, Inc. · 2006
- 1 generation backK101842 ACIESKonica Minolta Medical & Graphic, Inc. · 2011
- This deviceK133730 CO Pilot/Regius UniteaKonica Minolta, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK210066 ImagePilotKonica Minolta, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK240281 Bone Suppression SoftwareKonica Minolta, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −5 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −4 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −3 | K041555 | Securview DX Softcopy Workstation | Hologic, Inc. | 2004 | — |
| −2 | K062107 | Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003 | Hologic, Inc. | 2006 | — |
| −1 | K101842 | ACIES | Konica Minolta Medical & Graphic, Inc. | 2011 | — |
| 0 (this device) | K133730 | CO Pilot/Regius Unitea | Konica Minolta, Inc. | 2014 | — |
| +1 | K210066 | ImagePilot | Konica Minolta, Inc. | 2021 | 1 |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K071436 | Regius UniteaSummary page 1…Pilot 5. Common Name Picture Archiving Communications System 6. Classification, Product Code Class 11,90LLZ 7. Predicate Device REGIUS Unitea, 51 0(k) number K071436 Acies, 510(k) number K101 842 Opal-RAID TM, 510O(k) number K063337 8. Device Description The 'CO Pilot Software' is int… | 2007 |
| * | K101842 | ACIESSummary page 1…Archiving Communications System 6. Classification, Product Code Class 11,90LLZ 7. Predicate Device REGIUS Unitea, 51 0(k) number K071436 Acies, 510(k) number K101 842 Opal-RAID TM, 510O(k) number K063337 8. Device Description The 'CO Pilot Software' is intended for installation on REGIUS… | 2011 |
| * | K063337 | Opal-RadSummary page 1…sification, Product Code Class 11,90LLZ 7. Predicate Device REGIUS Unitea, 51 0(k) number K071436 Acies, 510(k) number K101 842 Opal-RAID TM, 510O(k) number K063337 8. Device Description The 'CO Pilot Software' is intended for installation on REGIUS Unitea (510(K) number: K071436), and… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210066 | ImagePilot | 2021 | 1 |
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 23 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K210066 (Konica Minolta, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K071436.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 CO pilot is intended for installation on an off-the-shelf PC (REGIUS Unitea /510(K) number: K071436) meeting or exceeding minimum specifications. The CO pilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The CO pilot software can process and display images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The CO pilot must not be used for primary image diagnosis in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133730: CO Pilot/Regius Unitea.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133730
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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