510(k) · Cleared
ClearedKonicaminolta DI-X1
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 Sep 13, 2021 as substantially equivalent to K182431 (Konica Minolta, Inc., 2018) after a 20-day review. Its family tree reaches back 1 generation to 2018. 3 later devices descend from it.
- Decided
- Sep 13, 2021
- Review
- 20 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K182431 (2018). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK182431 Konicaminolta DI-X1Konica Minolta, Inc. · 2018
- This deviceK212685 Konicaminolta DI-X1Konica Minolta, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK253029 RW-1Mediott, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK232456 RW-1Mediott, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK230906 Konicaminolta DI-X1Konica Minolta, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −1 | K182431 | Konicaminolta DI-X1 | Konica Minolta, Inc. | 2018 | — |
| 0 (this device) | K212685 | Konicaminolta DI-X1 | Konica Minolta, Inc. | 2021 | — |
| +1 | K253029 | RW-1 | Mediott, Inc. | 2026 | — |
| +1 | K232456 | RW-1 | Mediott, Inc. | 2025 | — |
| +1 | K230906 | Konicaminolta DI-X1 | Konica Minolta, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K182431 | Konicaminolta DI-X1Summary page 4…Management and Processing System Regulation Number: 21 CFR 892.2050 Regulatory Class: Class II Product Code(s): LLZ Predicate Device: K182431 - KONICAMINOLTA DI-X1 KONICA MINOLTA, INC. Regu… | 2018 |
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K253029 (Mediott, Inc., 2026) has gone furthest, with 0 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. 2021, 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?
KONICAMINOLTA DI-XI1 is a software device that receives digital x-ray images and data from various sources (i.e. R/F Units, digital radiographic devices or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and/or across computer networks at distributed locations. It is not intended for use in diagnostic review for mammography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212685: Konicaminolta DI-X1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212685
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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