510(k) · Cleared
ClearedMobileRay Pulse SE Digital Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portavision Medical, LLC · OWB Interventional Fluoroscopic X-Ray System
Cleared on Sep 4, 2019 as substantially equivalent to K160279 (Ecotron Co., Ltd., 2016) after a 90-day review. Its family tree reaches back 4 generations to 1997. 1 of the 14 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Sep 4, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K973598 (1997). 6 ancestors in all. 7 later devices descend from it, 2 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 3 generations backK022114 ImperiumElmstech, Inc. · 2002
- 2 generations backK032761 KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc. · 2004
- 1 generation backK160279 ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. · 2016
- This deviceK191503 MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 2019
- Descendant · cites it directly · 5 of its ownK211191 Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK241567 MC2 Portable X-ray SystemOxos Medical · 2024
- Descendant · 2 generations on · 1 of its ownK212523 VFSS Pro Mobile Digital Imaging SystemImagexray, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK212557 Virtual C DRF-NEO Digital Imaging SystemPortavision Medical, LLC · 2021
- Descendant · cites it directly · 1 of its ownK210469 Insight Agile DRFImaging Engineering, LLC · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K021049 Oec 9800 Plus Digital Mobile Imaging System3 generations back · 2002
Most influential descendants
Showing 5 of 7 · See all- K211191Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 2021 · cites it directly5descendants
- K241567MC2 Portable X-ray SystemOxos Medical · 2024 · 2 generations on1descendant
- K212523VFSS Pro Mobile Digital Imaging SystemImagexray, LLC · 2021 · 2 generations on1descendant
- K212557Virtual C DRF-NEO Digital Imaging SystemPortavision Medical, LLC · 2021 · 2 generations on1descendant
- K210469Insight Agile DRFImaging Engineering, LLC · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −3 | K022114 | Imperium | Elmstech, Inc. | 2002 | — |
| −2 | K032761 | KMC-950 C-Arm Mobile System | United Radiology Systems, Inc. | 2004 | — |
| −1 | K160279 | ANYVIEW-500R Fluoroscopic Mobile X-Ray System | Ecotron Co., Ltd. | 2016 | — |
| 0 (this device) | K191503 | MobileRay Pulse SE Digital Imaging System | Portavision Medical, LLC | 2019 | — |
| +1 | K211191 | Virtual C DRF Digital Imaging System | Portavision Medical, LLC | 2021 | — |
| +2 | K241567 | MC2 Portable X-ray System | Oxos Medical | 2024 | — |
| +2 | K212523 | VFSS Pro Mobile Digital Imaging System | Imagexray, LLC | 2021 | — |
| +2 | K212557 | Virtual C DRF-NEO Digital Imaging System | Portavision Medical, LLC | 2021 | — |
| +1 | K210469 | Insight Agile DRF | Imaging Engineering, 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K160279 | ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemSummary page 4…pic x-ray system Regulatory Class: II Product Codes: OWB, JAA, OXO Common/Usual Name: Mobile Fluoroscopic System 2. Equivalent legally marketed device: K160279 Trade/Device Name: AnyView 500R Fluoroscopic Mobile X-ray System Manufacturer: EcoTron Regulation Number: 21 CFR 8… | 2016 |
| † | K161942 | PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector | 2016 |
| † | K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | 2016 |
| † | K121410 | Dragon LW | 2012 |
What descends from it? (7)
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 · 3 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K211191 (Portavision Medical, LLC, 2021) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K160279.
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. 2019, 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?
Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device. The device provides radiographic, multi-radiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside and…
Read the full statement (125 words)
Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device. The device provides radiographic, multi-radiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside and outside of hospital, in a variety of procedures of the skull, spinal column, chest, abdomen, extremities. The device may be used for other imaging applications on all patients except pediatrics within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (RX Only)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191503 · printed Nov 4, 2026
Cite this page
510(k) Report. “K191503: MobileRay Pulse SE Digital Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K191503
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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