510(k) · Cleared
ClearedANYVIEW-500R Fluoroscopic Mobile X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ecotron Co., Ltd. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Oct 14, 2016 as substantially equivalent to K032761 (United Radiology Systems, Inc., 2004) after a 255-day review. Its family tree reaches back 3 generations to 1997. 1 of the 15 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Oct 14, 2016
- Review
- 255 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K973598 (1997). 5 ancestors in all. 9 later devices descend from it, 2 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 2 generations backK022114 ImperiumElmstech, Inc. · 2002
- 1 generation backK032761 KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc. · 2004
- This deviceK160279 ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. · 2016
- Descendant · cites it directly · 7 of its ownK191503 MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 2019
- Descendant · 2 generations on · 5 of its ownK211191 Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 2021
- Descendant · 3 generations on · 1 of its ownK241567 MC2 Portable X-ray SystemOxos Medical · 2024
- Descendant · 3 generations on · 1 of its ownK212523 VFSS Pro Mobile Digital Imaging SystemImagexray, LLC · 2021
- Descendant · 3 generations on · 1 of its ownK212557 Virtual C DRF-NEO Digital Imaging SystemPortavision Medical, LLC · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K021049 Oec 9800 Plus Digital Mobile Imaging System2 generations back · 2002
Most influential descendants
Showing 5 of 9 · See all- K191503MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 2019 · cites it directly7descendants
- K211191Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 2021 · 2 generations on5descendants
- K241567MC2 Portable X-ray SystemOxos Medical · 2024 · 3 generations on1descendant
- K212523VFSS Pro Mobile Digital Imaging SystemImagexray, LLC · 2021 · 3 generations on1descendant
- K212557Virtual C DRF-NEO Digital Imaging SystemPortavision Medical, LLC · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −2 | K022114 | Imperium | Elmstech, Inc. | 2002 | — |
| −1 | K032761 | KMC-950 C-Arm Mobile System | United Radiology Systems, Inc. | 2004 | — |
| 0 (this device) | K160279 | ANYVIEW-500R Fluoroscopic Mobile X-Ray System | Ecotron Co., Ltd. | 2016 | — |
| +1 | K191503 | MobileRay Pulse SE Digital Imaging System | Portavision Medical, LLC | 2019 | — |
| +2 | K211191 | Virtual C DRF Digital Imaging System | Portavision Medical, LLC | 2021 | — |
| +3 | K241567 | MC2 Portable X-ray System | Oxos Medical | 2024 | — |
| +3 | K212523 | VFSS Pro Mobile Digital Imaging System | Imagexray, LLC | 2021 | — |
| +3 | K212557 | Virtual C DRF-NEO Digital Imaging System | Portavision Medical, LLC | 2021 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K032761 | KMC-950 C-Arm Mobile SystemSummary page 5…ulatory Class: II Product Code: OWB, JAA, OXO Predicate Device Trade Name KMC-950 510(k) Clearance # K032761 Clearance date 05/14/2004 Classification Name Image Intensified Fluoroscopic X-ray System Classif… | 2004 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K191503 (Portavision Medical, LLC, 2019) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K032761.
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. 2016, 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?
Anyview-500R fluoroscopic mobile x-ray system is radiation medical equipment only used by professional radiologists.
This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures.
This system can be applied in emergency room, operation room, cast room or etc. of hospital.
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/K160279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160279: ANYVIEW-500R Fluoroscopic Mobile 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/K160279
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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