510(k) · Cleared
Recalled · Class II · 2026MC2 Portable X-ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxos Medical · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 22, 2025 as substantially equivalent to K241567 (Oxos Medical, 2024) after a 174-day review. Its family tree reaches back 7 generations to 1997. 1 of the 10 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Dec 22, 2025
- Review
- 174 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K973598 (1997). 9 ancestors in all. No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations backK022114 ImperiumElmstech, Inc. · 2002
- 5 generations backK032761 KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc. · 2004
- 4 generations backK160279 ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. · 2016
- 3 generations backK191503 MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 2019
- 2 generations backK211191 Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 2021
- 1 generation backK241567 MC2 Portable X-ray SystemOxos Medical · 2024
- This deviceK252068 MC2 Portable X-ray SystemOxos Medical · 2025
Class I recalls in this family
- K021049 Oec 9800 Plus Digital Mobile Imaging System6 generations back · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −6 | K022114 | Imperium | Elmstech, Inc. | 2002 | — |
| −5 | K032761 | KMC-950 C-Arm Mobile System | United Radiology Systems, Inc. | 2004 | — |
| −4 | K160279 | ANYVIEW-500R Fluoroscopic Mobile X-Ray System | Ecotron Co., Ltd. | 2016 | — |
| −3 | K191503 | MobileRay Pulse SE Digital Imaging System | Portavision Medical, LLC | 2019 | — |
| −2 | K211191 | Virtual C DRF Digital Imaging System | Portavision Medical, LLC | 2021 | — |
| −1 | K241567 | MC2 Portable X-ray System | Oxos Medical | 2024 | — |
| 0 (this device) | K252068 | MC2 Portable X-ray System | Oxos Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K241567 | MC2 Portable X-ray SystemSummary page 6…OWB, OXO, IZL Legally Marketed Predicate Devices Type K-Number Trade Name Product Code Predicate K241567 MC2 Portable X-ray System OWB, OXO, IZL Reference K212654 Micro C Medical Imaging Syste… | 2024 |
| † | K212654 | Micro C Medical Imaging System, M01 | 2022 |
| † | K211191 | Virtual C DRF Digital Imaging System | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 11, 2026 | Class II | Z-2857-2026 | Process change control | Due to a defective circuit board that overheats |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 6 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult and pediatric patients for: - Handheld orthopedic radiographic procedures of the extremities. - Handheld orthopedic serial radiographic procedures of the extremities, excluding the shoulder, hip, and knee. Handheld serial radiographic imaging is limited to forward holding position only. - Stand-mounted orthopedic radiographic, serial radiographic…
Read the full statement (257 words)
The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult and pediatric patients for:
- Handheld orthopedic radiographic procedures of the extremities.
- Handheld orthopedic serial radiographic procedures of the extremities, excluding the shoulder, hip, and knee. Handheld serial radiographic imaging is limited to forward holding position only.
- Stand-mounted orthopedic radiographic, serial radiographic, fluoroscopic, and orthopedic interventional procedures of the extremities, inclusive of shoulders and knees.
The device is NOT intended for use during surgery. The device is NOT intended to replace a stationary radiographic or fluoroscopic system, which may be required for optimization of image quality and radiation exposure.
The device is to be used in healthcare facilities where qualified operators are present (e.g., outpatient clinics, urgent cares, imaging centers, sports medicine facilities, occupational medicine clinics).
The device is NOT intended to be used in environments with the following characteristics:
-Aseptic or sterile fields, such as in surgery
-Home or residential settings or other settings where qualified operators are not present
-Vehicular and moving environments
-Environments under direct sunlight
-Oxygen-rich environments, such as near an operating oxygenation concentrator
Contraindications
The MC2 System is contraindicated as follows:
The MC2 System is NOT intended for bariatric patients.
The MC2 System is NOT intended for mammography.
The MC2 System is NOT intended for dental applications.
The MC2 System is NOT intended to come in contact with non-intact skin.
The MC2 System is NOT intended for cardiac applications.
The MC2 System is NOT intended for use in proximity to pacemakers or implantable cardioverter-defibrillators (ICDs).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252068 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252068: MC2 Portable X-ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252068
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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