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 Feb 4, 2022 as substantially equivalent to K211473 (Oxos Medical, Inc., 2021) after a 165-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Feb 4, 2022
- Review
- 165 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945707 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK945707 Minxray HF80H High Frequency Diagnostic X-Ray UnitMinxray, Inc. · 1995
- 5 generations backK973712 Minxray HF100H High Frequency Diagnostic X-Ray UnitMinxray, Inc. · 1997
- 4 generations backK052721 Minxray, Model HF100H+Minxray, Inc. · 2005
- 3 generations backK140723 Nomad MD 75K V Handheld X-Ray SystemAribex, Inc. · 2014
- 2 generations backK203658 Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021
- 1 generation backK211473 Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021
- This deviceK212654 Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945707 | Minxray HF80H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1995 | — |
| −5 | K973712 | Minxray HF100H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1997 | — |
| −4 | K052721 | Minxray, Model HF100H+ | Minxray, Inc. | 2005 | — |
| −3 | K140723 | Nomad MD 75K V Handheld X-Ray System | Aribex, Inc. | 2014 | — |
| −2 | K203658 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2021 | — |
| −1 | K211473 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2021 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K211473 | Micro C Medical Imaging System, M01Summary page 4…nel: Radiology Predicate Device: Legally marketed device to which substantial equivalence is claimed: Micro C Medical Imaging System, M01 (K211473) Device Description: The Micro C Medical Imaging System, M01 (subject device) is a handheld X-ray system designed to aid clinici… | 2021 |
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 27 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 and pediatric 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212654 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212654: Micro C Medical Imaging System, M01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212654
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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