510(k) Report

510(k) · Cleared

Cleared

KMC-950 C-Arm Mobile System

K032761510(k) TraditionalCleared May 14, 2004252-day reviewClass II21 CFR 892.1650

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

United Radiology Systems, Inc. · OWB Interventional Fluoroscopic X-Ray System

Cleared on May 14, 2004 as substantially equivalent to K021049 (Ge Oec Medical Systems, 2002) and 3 other predicates after a 252-day review. Its family tree reaches back 2 generations to 1997. 1 of the 19 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.

Decided
May 14, 2004
Review
252 days
Class
Class II
Product code
OWB
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K973598 (1997). 4 ancestors in all. 14 later devices descend from it, 5 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor, 1 with a Class I recall12000: 1 other ancestor2020: 1 descendant cleared2016: 2 descendants cleared2017: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant cleared2021: 4 descendants cleared2025: 2 descendants cleared2024: 1 descendant clearedK973598 · Siremobil CO2 · Siemens Medical Solutions USA, Inc. · 1997 · recalledK022114 · Imperium · Elmstech, Inc. · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors, 1 with a Class I recall1 1 generation forward: 5 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 4 descendants5 generations forward: 1 descendant K022114 · Imperium · Elmstech, Inc. · 2002K973598 · Siremobil CO2 · Siemens Medical Solutions USA, Inc. · 1997 · recalled0+5
  1. Root · 2 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
  2. 1 generation backK022114 ImperiumElmstech, Inc. · 2002
  3. This deviceK032761 KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc. · 2004
  4. Descendant · cites it directly · 9 of its ownK160279 ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. · 2016
  5. Descendant · 2 generations on · 7 of its ownK191503 MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 2019
  6. Descendant · 3 generations on · 5 of its ownK211191 Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 2021
  7. Descendant · 4 generations on · 1 of its ownK241567 MC2 Portable X-ray SystemOxos Medical · 2024
  8. Descendant · 4 generations on · 1 of its ownK212523 VFSS Pro Mobile Digital Imaging SystemImagexray, LLC · 2021

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2014: 12016: 22017: 12018: 12019: 12020: 12021: 42024: 12025: 2
2014high 4 (2021) · low 0 (2015)2026

Class I recalls in this family

  • K021049 Oec 9800 Plus Digital Mobile Imaging Systemdirect predicate · 2002

Most influential descendants

Showing 5 of 14 · See all
  • K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. · 2016 · cites it directly9descendants
  • K191503MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 2019 · 2 generations on7descendants
  • K211191Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 2021 · 3 generations on5descendants
  • K241567MC2 Portable X-ray SystemOxos Medical · 2024 · 4 generations on1descendant
  • K212523VFSS Pro Mobile Digital Imaging SystemImagexray, LLC · 2021 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K973598Siremobil CO2Siemens Medical Solutions USA, Inc.19971
−1K022114ImperiumElmstech, Inc.2002—
0 (this device)K032761KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc.2004—
+1K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd.2016—
+2K191503MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC2019—
+3K211191Virtual C DRF Digital Imaging SystemPortavision Medical, LLC2021—
+4K241567MC2 Portable X-ray SystemOxos Medical2024—
+4K212523VFSS Pro Mobile Digital Imaging SystemImagexray, LLC2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200211

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201620
201710
201810
201910
202010
202140
202410
202520
FIG. 1 — Lineage of K032761, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K021049Oec 9800 Plus Digital Mobile Imaging System
Summary page 2
…are substantially equivalenl to a legally marketed predicate devices and 510(k) numbers with regard to safety and effectiveness as following list : ¢ GE OEC 9800 PLUS : K 021049 ¢ Siemens, Siremobile 1ISO-C : K 973598 & Medison Acoma, MCA-6100 : K993896 & ELMSTech. IMPERIUM : K022114 Performance Standard…
Ge Oec Medical Systems2002Class I
*K973598Siremobil CO2
Summary page 2
…marketed predicate devices and 510(k) numbers with regard to safety and effectiveness as following list : ¢ GE OEC 9800 PLUS : K 021049 ¢ Siemens, Siremobile 1ISO-C : K 973598 & Medison Acoma, MCA-6100 : K993896 & ELMSTech. IMPERIUM : K022114 Performance Standards : The KMC-950 is designed in accordanc…
Siemens Medical Solutions USA, Inc.19971
*K993896Mca-601, C-Arm Mobile
Summary page 2
…) numbers with regard to safety and effectiveness as following list : ¢ GE OEC 9800 PLUS : K 021049 ¢ Siemens, Siremobile 1ISO-C : K 973598 & Medison Acoma, MCA-6100 : K993896 & ELMSTech. IMPERIUM : K022114 Performance Standards : The KMC-950 is designed in accordance with the national and imemafional…
Medison Radiology Systems, Inc.2000—
*K022114Imperium
Summary page 2
…and effectiveness as following list : ¢ GE OEC 9800 PLUS : K 021049 ¢ Siemens, Siremobile 1ISO-C : K 973598 & Medison Acoma, MCA-6100 : K993896 & ELMSTech. IMPERIUM : K022114 Performance Standards : The KMC-950 is designed in accordance with the national and imemafional product safety and performance…
Elmstech, Inc.2002—

Also cleared against K021049: 5 other devices →

What descends from it? (14)

See all 14

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd.20169
K200022FLUSION-9001, Fluoroscopic C-arm Mobile X-ray SystemLivermoretech, Inc.20200
K163140SPINEL 12HD Interventional Fluoroscopic Mobile X-ray SystemGemss Medical Systems Co., Ltd.20170
K160065GEMSS Medical System Surgical Mobile Fluoroscopic X-ray SystemGemss Medical Systems Co., Ltd.20160
K132289Gemss Medical Systems Surgical Mobile Fluoroscopic X-Ray SystemGemss Medical Systems Co., Ltd.20140

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?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
  • 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K160279 (Ecotron Co., Ltd., 2016) has gone furthest, with 9 descendants of its own.
  • 5 other devices also cite its predicate K021049.

How does its category compare?

All OWB devices

OWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OWB

22in 2025

2007: 32008: 42009: 92010: 72011: 62012: 62013: 112014: 152015: 112016: 162017: 202018: 232019: 92020: 162021: 242022: 212023: 122024: 132025: 222026 (partial year): 15
2007high 24 (2021) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OWB

148in 2025

2007: 52 days median2008: 135 days median2009: 99 days median2010: 66 days median2011: 79 days median2012: 37 days median2013: 119 days median2014: 158 days median2015: 66 days median2016: 103 days median2017: 76 days median2018: 54 days median2019: 174 days median2020: 53 days median2021: 60 days median2022: 90 days median2023: 152 days median2024: 126 days median2025: 148 days median2026 (partial year): 221 days median
2007high 221 (2026) · low 37 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OWB

42so far in 2026, the most since 2007

2008: 12013: 102014: 92015: 352016: 132017: 132018: 62019: 72020: 82021: 312022: 242023: 222024: 112025: 302026 (partial year): 42
2007high 42 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OWB

14,008in 2025

2007: 12011: 12012: 12013: 272014: 1032015: 2,1342016: 4,0742017: 1,6042018: 1,4492019: 1,5582020: 1,5812021: 1,9812022: 2,9322023: 7,6042024: 7,9422025: 14,008
2007high 14,008 (2025) · low 0 (2008)2025

MAUDE reports naming product code OWB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735201
2008413510
200999900
201076600
201167901
201263701
2013111191027
2014151589103
20151166352,134
201616103134,074
20172076131,604
2018235461,449
2019917471,558
2020165381,581
20212460311,981
20222190242,932
202312152227,604
202413126117,942
2025221483014,008
20261522142—

What is it indicated for?

The KMC-950 is intended to provided 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, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.

The system may be used for other RF imaging application 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.

Also cleared against K021049

5 other devices cite the same predicate.

  • K121303Mobile C-ArmCanon Inc. -Medical Equipment Group · 2012
  • K103425Zen-7000, Fluoroscopic X-Ray SystemGenoray America, Inc. · 2011
  • K061203Ziehm Vision R Digital Mobile Imaging SystemZiehm Imaging, Inc. · 20064 recalls
  • K041932Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 20047 recalls
  • K022114ImperiumElmstech, Inc. · 2002

More from United Radiology Systems, Inc.

2 FDA decisions under this applicant name. See the company

  • K032628Portable X-Ray Unit, Models PXP-15/20/40HFUnited Radiology Systems, Inc. · 2004

Recent decisions in OWB

The OWB category page

  • K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd. · 2026
  • K261413Extron 3;Extron 6DRTECH Corporation · 2026
  • K254205Zenition 30Philips Medical Systems Nederland B.V. · 2026
  • K260607Shield System (Siemens 30x40)Radiaction, Ltd. · 2026
  • K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V. · 2026

https://510kreport.com/device/K032761 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032761: KMC-950 C-Arm Mobile System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032761

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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