510(k) · Cleared
ClearedMC2 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 6, 2024 as substantially equivalent to K211191 (Portavision Medical, LLC, 2021) after a 189-day review. Its family tree reaches back 6 generations to 1997. 1 of the 10 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 6, 2024
- Review
- 189 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K973598 (1997). 8 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations backK022114 ImperiumElmstech, Inc. · 2002
- 4 generations backK032761 KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc. · 2004
- 3 generations backK160279 ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. · 2016
- 2 generations backK191503 MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 2019
- 1 generation backK211191 Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 2021
- This deviceK241567 MC2 Portable X-ray SystemOxos Medical · 2024
- Descendant · cites it directly · 0 of its ownK252068 MC2 Portable X-ray SystemOxos Medical · 2025 · Recalled
Class I recalls in this family
- K021049 Oec 9800 Plus Digital Mobile Imaging System5 generations back · 2002
Most influential descendants
Showing 1 of 1 · See all- K252068MC2 Portable X-ray SystemOxos Medical · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −5 | K022114 | Imperium | Elmstech, Inc. | 2002 | — |
| −4 | K032761 | KMC-950 C-Arm Mobile System | United Radiology Systems, Inc. | 2004 | — |
| −3 | K160279 | ANYVIEW-500R Fluoroscopic Mobile X-Ray System | Ecotron Co., Ltd. | 2016 | — |
| −2 | K191503 | MobileRay Pulse SE Digital Imaging System | Portavision Medical, LLC | 2019 | — |
| −1 | K211191 | Virtual C DRF Digital Imaging System | Portavision Medical, LLC | 2021 | — |
| 0 (this device) | K241567 | MC2 Portable X-ray System | Oxos Medical | 2024 | — |
| +1 | K252068 | MC2 Portable X-ray System | Oxos Medical | 2025 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
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 |
|---|---|---|---|
| * | K211191 | Virtual C DRF Digital Imaging SystemSummary page 5…OWB, OXO, IZL Legally Marketed Predicate Devices Type K-Number Trade Name Product Code Predicate K211191 Virtual C DRF Digital Imaging System OWB Reference K182207 MinXray, Inc. TR90BH… | 2021 |
| † | K182207 | TR90BH | 2018 |
| † | K193225 | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System… | 2020 |
| † | K221714 | Flat Panel Detector | 2022 |
| † | K150150 | 1717SGN / 1717SCN Digital Flat Panel X-ray Detector | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252068 | MC2 Portable X-ray System | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 5 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K252068 (Oxos Medical, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K211191.
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. 2024, 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 patients for orthopedic radiographic, orthopedic serial radiographic, orthopedic fluoroscopic, and orthopedic interventional procedures of extremities distal to the shoulders and distal to the knees. The device is not intended for use during surgery. The device is not intended to replace a stationary radiographic system. The device is to be used in…
Read the full statement (138 words)
The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult patients for orthopedic radiographic, orthopedic serial radiographic, orthopedic fluoroscopic, and orthopedic interventional procedures of extremities distal to the shoulders and distal to the knees. The device is not intended for use during surgery. The device is not intended to replace a stationary radiographic system.
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241567 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241567: MC2 Portable X-ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241567
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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