510(k) · Cleared
Recalled · Class II · 2018Regius Unitea
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 Jun 27, 2007 as substantially equivalent to K051523 (Konica Minolta Medical & Graphic, Inc., 2005) after a 35-day review. Its family tree reaches back 2 generations to 2004. 4 later devices descend from it. It has been recalled once.
- Decided
- Jun 27, 2007
- Review
- 35 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041990 (2004). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK041990 Fuji Medical CR Console, Model Flash IipFujifilm Medical System U.S.A., Inc. · 2004
- 1 generation backK051523 Regius Console CS-2000 and Regius Console CS-3000, Medical Image…Konica Minolta Medical & Graphic, Inc. · 2005 · Recalled
- This deviceK071436 Regius UniteaKonica Minolta Medical & Graphic, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK101842 ACIESKonica Minolta Medical & Graphic, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK133730 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 4 of 4 · See all- K101842ACIESKonica Minolta Medical & Graphic, Inc. · 2011 · cites it directly3descendants
- K133730CO Pilot/Regius UniteaKonica Minolta, Inc. · 2014 · cites it directly2descendants
- K210066ImagePilotKonica Minolta, Inc. · 2021 · cites it directly1descendant
- K240281Bone Suppression SoftwareKonica Minolta, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041990 | Fuji Medical CR Console, Model Flash Iip | Fujifilm Medical System U.S.A., Inc. | 2004 | — |
| −1 | K051523 | Regius Console CS-2000 and Regius Console CS-3000, Medical Image Processing… | Konica Minolta Medical & Graphic, Inc. | 2005 | 1 |
| 0 (this device) | K071436 | Regius Unitea | Konica Minolta Medical & Graphic, Inc. | 2007 | — |
| +1 | K101842 | ACIES | Konica Minolta Medical & Graphic, Inc. | 2011 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K051523 | Regius Console CS-2000 and Regius Console CS-3000, Medical Image Processing WorkstationSummary page 1…n 7. Classification Class I, 90 LLZ, 21 CFR 892. 2050, Picture archiving and communications system 8. Predicate Device REGIUS CS-2000 and CS-3000, 510(k) number: K051523 cleared on Jul.20,2005 9. Description of Device REGIUS Unitea is a software which is intended for installation on an off-the-… | 2005 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2018 | Class II | Z-2282-2018 | Unknown/Undetermined by firm | Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignition (fire) in CF-C2 "Toughbook" laptops. Since Konica Minolta uses this laptop in some of its product configurations, it notified its… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K101842 (Konica Minolta Medical & Graphic, Inc., 2011) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 REGIUS Unitea software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The REGIUS Unitea software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The REGIUS Unitea software can process and display medical 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 REGIUS Unitea must not be used for primary image diagnosis in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071436: 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/K071436
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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