510(k) Report

510(k) · Cleared

Cleared

New Brid

K041780510(k) TraditionalCleared Aug 11, 200441-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

Medical Imaging Solutions, Inc. · OWB Interventional Fluoroscopic X-Ray System

Cleared on Aug 11, 2004 as substantially equivalent to K984545 (Philips Medical Systems North America, Inc., 1999) and 2 other predicates after a 41-day review. Its family tree reaches back 3 generations to 1989.

Decided
Aug 11, 2004
Review
41 days
Class
Class II
Product code
OWB
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K890348 (1989). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestorK890348 · LC, Cardiac Positioner #B5078A · General Electric Co. · 1989 · recalledK993037 · LCV+ Version 2 · Ge Medical Systems, Inc. · 2000 · recalledK023178 · Innova 4100 · Ge Medical Systems, Inc. · 2002 · recalled19851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors3 generations back: 2 other ancestors K023178 · Innova 4100 · Ge Medical Systems, Inc. · 2002 · recalledK993037 · LCV+ Version 2 · Ge Medical Systems, Inc. · 2000 · recalledK890348 · LC, Cardiac Positioner #B5078A · General Electric Co. · 1989 · recalled0
  1. Root · 3 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
  2. 2 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
  3. 1 generation backK023178 Innova 4100Ge Medical Systems, Inc. · 2002 · Recalled
  4. This deviceK041780 New BridMedical Imaging Solutions, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K890348LC, Cardiac Positioner #B5078AGeneral Electric Co.19895
−2K993037LCV+ Version 2Ge Medical Systems, Inc.20006
−1K023178Innova 4100Ge Medical Systems, Inc.200225
0 (this device)K041780New BridMedical Imaging Solutions, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510
199610
199910
FIG. 1 — Lineage of K041780, 1989–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

Planning a device in OWB? 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
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What was it cleared against? (3)

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
*K984545Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems
Summary page 2
…cian’s discretion. 7. PREDICATE DEVICE(s): The MIS Newbrid System is substantially equivalent, in terms of its intended use in; Philips Integris Series [K984545) GE Medical System Advantx LCV+ [K960575] GE Medical System Innova [K023178] 8. SAFETY INFORMATION: The finished device and i…
Philips Medical Systems North America, Inc.199917
*K960575Advantx LCV+
Summary page 2
…ICATE DEVICE(s): The MIS Newbrid System is substantially equivalent, in terms of its intended use in; Philips Integris Series [K984545) GE Medical System Advantx LCV+ [K960575] GE Medical System Innova [K023178] 8. SAFETY INFORMATION: The finished device and its peripherals will comply with applicable…
GE Medical Systems19966
*K023178Innova 4100
Summary page 2
…stem is substantially equivalent, in terms of its intended use in; Philips Integris Series [K984545) GE Medical System Advantx LCV+ [K960575] GE Medical System Innova [K023178] 8. SAFETY INFORMATION: The finished device and its peripherals will comply with applicable requirements of the Underwriter Lab…
Ge Medical Systems, Inc.200225

Also cleared against K984545: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
  • 5 of the 7 ancestors have a recall of any class.
  • 7 other devices also cite its predicate K984545.

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 system is intended for use in cardiovascular x-ray imaging applications, including diagnostic and interventional procedures (such as PTCA, stent placement, atherectomies), pacemaker implantations, and electrophysiology. It may also be used for other imaging applications at the 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 K984545

7 other devices cite the same predicate.

  • K130842Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura Xper FD Biplane…Philips Medical Systems Nederland B.V. · 201311 Class I recalls
  • K070834CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc. · 2007
  • K062647E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc. · 2006
  • K042961Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 20051 recall
  • K031836Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
  • K020055Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 20022 recalls

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/K041780 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041780: New Brid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041780

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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