510(k) · Cleared
ClearedRemex KA6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remedi Co., Ltd. · IZL System, X-Ray, Mobile
Cleared on Aug 3, 2021 as substantially equivalent to K182207 (Minxray, Inc., 2018) after a 25-day review. Its family tree reaches back 3 generations to 2004. 3 later devices descend from it.
- Decided
- Aug 3, 2021
- Review
- 25 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040046 (2004). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK040046 Minxray, Model HF120/60H PowerplusMinxray, Inc. · 2004
- 2 generations backK153059 HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc. · 2016
- 1 generation backK182207 TR90BHMinxray, Inc. · 2018
- This deviceK212144 Remex KA6Remedi Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK243864 BONX805Bontech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243473 Prorad Atlas Ultraportable; Prorad Atlas Ultraportable PlusPrognosys Medical Systems Private Limited · 2025
- Descendant · cites it directly · 0 of its ownK213405 MINE ALNU (Model: Mine 2.1)Hdt Co., Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See all- K243864BONX805Bontech Co., Ltd. · 2025 · cites it directly0descendants
- K243473Prorad Atlas Ultraportable; Prorad Atlas Ultraportable PlusPrognosys Medical Systems Private Limited · 2025 · cites it directly0descendants
- K213405MINE ALNU (Model: Mine 2.1)Hdt Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040046 | Minxray, Model HF120/60H Powerplus | Minxray, Inc. | 2004 | — |
| −2 | K153059 | HF1202H PowerPlus Portable X-ray Equipment | Minxray, Inc. | 2016 | — |
| −1 | K182207 | TR90BH | Minxray, Inc. | 2018 | — |
| 0 (this device) | K212144 | Remex KA6 | Remedi Co., Ltd. | 2021 | — |
| +1 | K243864 | BONX805 | Bontech Co., Ltd. | 2025 | — |
| +1 | K243473 | Prorad Atlas Ultraportable; Prorad Atlas Ultraportable Plus | Prognosys Medical Systems Private Limited | 2025 | — |
| +1 | K213405 | MINE ALNU (Model: Mine 2.1) | Hdt Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 2 | 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 IZL? 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 IZL device
- #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 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 |
|---|---|---|---|
| * | K182207 | TR90BHSummary page 5…5-1 Predicate Devices The following predicates are legally marketed, post-amendment devices: 510(k) Number: K182207 Clearance Date: December 14, 2018 510(k) Trade Name: MinXray TR90BH Submitters: Mikasa X-Ray Co., Ltd. (Tokyo, Japan)… | 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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K243864 (Bontech Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K182207.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 2025
MAUDE reports naming product code IZL, 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 | 3 | 30 | 7 | 16 |
| 2008 | 4 | 49 | 0 | 27 |
| 2009 | 3 | 125 | 0 | 35 |
| 2010 | 3 | 65 | 4 | 75 |
| 2011 | 6 | 66 | 6 | 118 |
| 2012 | 3 | 83 | 5 | 24 |
| 2013 | 0 | — | 10 | 17 |
| 2014 | 7 | 104 | 4 | 51 |
| 2015 | 4 | 88 | 4 | 30 |
| 2016 | 6 | 47 | 0 | 33 |
| 2017 | 7 | 45 | 0 | 35 |
| 2018 | 8 | 47 | 0 | 27 |
| 2019 | 9 | 33 | 2 | 40 |
| 2020 | 9 | 43 | 1 | 48 |
| 2021 | 13 | 48 | 0 | 47 |
| 2022 | 16 | 89 | 1 | 32 |
| 2023 | 3 | 55 | 6 | 77 |
| 2024 | 9 | 159 | 5 | 39 |
| 2025 | 11 | 153 | 47 | 27 |
| 2026 | 6 | 157 | 5 | — |
What is it indicated for?
The KAG6 is a portable X-ray system for diagnostic imaging of body extremities.
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/K212144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212144: Remex KA6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212144
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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