510(k) · Cleared
ClearedImperium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elmstech, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Sep 17, 2002 as substantially equivalent to K021049 (Ge Oec Medical Systems, 2002) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1997. 1 of the 18 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.
- Decided
- Sep 17, 2002
- Review
- 81 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973598 (1997). 2 ancestors in all. 15 later devices descend from it, 1 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- This deviceK022114 ImperiumElmstech, Inc. · 2002
- Descendant · cites it directly · 14 of its ownK032761 KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc. · 2004
- Descendant · 2 generations on · 9 of its ownK160279 ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. · 2016
- Descendant · 3 generations on · 7 of its ownK191503 MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 2019
- Descendant · 4 generations on · 5 of its ownK211191 Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 2021
- Descendant · 5 generations on · 1 of its ownK241567 MC2 Portable X-ray SystemOxos Medical · 2024
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K021049 Oec 9800 Plus Digital Mobile Imaging Systemdirect predicate · 2002
Most influential descendants
Showing 5 of 15 · See all- K032761KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc. · 2004 · cites it directly14descendants
- K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. · 2016 · 2 generations on9descendants
- K191503MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 2019 · 3 generations on7descendants
- K211191Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 2021 · 4 generations on5descendants
- K241567MC2 Portable X-ray SystemOxos Medical · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| 0 (this device) | K022114 | Imperium | Elmstech, Inc. | 2002 | — |
| +1 | K032761 | KMC-950 C-Arm Mobile System | United Radiology Systems, Inc. | 2004 | — |
| +2 | K160279 | ANYVIEW-500R Fluoroscopic Mobile X-Ray System | Ecotron Co., Ltd. | 2016 | — |
| +3 | K191503 | MobileRay Pulse SE Digital Imaging System | Portavision Medical, LLC | 2019 | — |
| +4 | K211191 | Virtual C DRF Digital Imaging System | Portavision Medical, LLC | 2021 | — |
| +5 | K241567 | MC2 Portable X-ray System | Oxos Medical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K021049 | Oec 9800 Plus Digital Mobile Imaging SystemSummary page 2…3. 4. Substantial Equivalence The IMPERIUM MOBILE C-ARM X-RAY EQUIPMENT is substantially equivalent to the following currently marketed devices: o GE OEC 9800 PLUS (K021049) SIEMENS MEDICAL SIREMOBIL ISO-C (K973598) Description of Device The IMPERIUM is a mobile c-arm x-ray imaging equipment consist… | 2002 |
| * | K973598 | Siremobil CO2Summary page 2…RIUM MOBILE C-ARM X-RAY EQUIPMENT is substantially equivalent to the following currently marketed devices: o GE OEC 9800 PLUS (K021049) SIEMENS MEDICAL SIREMOBIL ISO-C (K973598) Description of Device The IMPERIUM is a mobile c-arm x-ray imaging equipment consisting of a c- arm stand and a monitor trolle… | 1997 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032761 | KMC-950 C-Arm Mobile System | 2004 | 14 |
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 · Direct predicate · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
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.
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 IMPERIUM is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography (DSA), orthopedic, neurologic, abdominal, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at physician’s discretion.
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/K022114 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022114: Imperium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022114
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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