510(k) · Cleared
ClearedMicro C Medical Imaging System, M01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxos Medical, Inc. · IZL System, X-Ray, Mobile
Cleared on Jan 12, 2021 as substantially equivalent to K140723 (Aribex, Inc., 2014) after a 28-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 12, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945707 (1995). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK945707 Minxray HF80H High Frequency Diagnostic X-Ray UnitMinxray, Inc. · 1995
- 3 generations backK973712 Minxray HF100H High Frequency Diagnostic X-Ray UnitMinxray, Inc. · 1997
- 2 generations backK052721 Minxray, Model HF100H+Minxray, Inc. · 2005
- 1 generation backK140723 Nomad MD 75K V Handheld X-Ray SystemAribex, Inc. · 2014
- This deviceK203658 Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK211473 Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK212654 Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2022
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 |
|---|---|---|---|---|---|
| −4 | K945707 | Minxray HF80H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1995 | — |
| −3 | K973712 | Minxray HF100H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1997 | — |
| −2 | K052721 | Minxray, Model HF100H+ | Minxray, Inc. | 2005 | — |
| −1 | K140723 | Nomad MD 75K V Handheld X-Ray System | Aribex, Inc. | 2014 | — |
| 0 (this device) | K203658 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2021 | — |
| +1 | K211473 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2021 | — |
| +2 | K212654 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K140723 | Nomad MD 75K V Handheld X-Ray SystemSummary page 4…nel: Radiology Predicate Device: Legally marketed device to which substantial equivalence is claimed: Nomad MD 75kV Handheld X-Ray System (K140723) Reference Devices: KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR™ AU S… | 2014 |
| † | K193225 | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System… | 2020 |
| † | K173309 | Faxitron VisionCT | 2018 |
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 |
|---|---|---|---|
| K211473 | Micro C Medical Imaging System, M01 | 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 26 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K211473 (Oxos Medical, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K140723.
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 Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that 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/K203658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203658: Micro C Medical Imaging System, M01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203658
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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