510(k) · Cleared
ClearedREMEX Xcam6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remedi, Inc. · IZL System, X-Ray, Mobile
Cleared on Jul 31, 2025 as substantially equivalent to K182207 (Minxray, Inc., 2018) after a 153-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Jul 31, 2025
- Review
- 153 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040046 (2004). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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…: TR90BH Common name: System, X-Ray, Mobile Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Product Code: IZL Regulatory Class: II 510(k) Number: K182207 1… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- None of the 3 ancestors has a recall.
- 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. 2025, 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?
Portable X-ray Equipment REMEX Xcam6 is intended to be used in a hospital or clinic setting under the supervision of a qualified and trained clinician. This product is used as an x-ray source to produce diagnostic x-ray images of patient's extremities using an X-ray detector. It may be used in handheld or stand-mounted configurations for acquiring diagnostic radiographic images of extremities.
The device is not intended for mammography.
The REMEX Xcam6 is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250597 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250597: REMEX Xcam6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250597
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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