510(k) Report

510(k) · Cleared

Cleared

O-arm O2 Imaging System

K200074510(k) TraditionalCleared Apr 24, 2020101-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

Medtronic, Inc. · OWB Interventional Fluoroscopic X-Ray System

Cleared on Apr 24, 2020 as substantially equivalent to K173664 (Medtronic, Inc., 2017) after a 101-day review. Its family tree reaches back 7 generations to 2000. 2 of the 23 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.

Decided
Apr 24, 2020
Review
101 days
Class
Class II
Product code
OWB
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K003266 (2000). 9 ancestors in all. 13 later devices descend from it, 3 citing it directly. 2 of the 23 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors, 1 with a Class I recall12022: 1 descendant cleared2021: 2 descendants cleared, 1 with a Class I recall12024: 6 descendants cleared2025: 3 descendants cleared2026: 1 descendant clearedK003266 · Siremobil Iso-C 3D · Siemens Medical Solutions USA, Inc. · 2000K032280 · Siremobil Iso-C 3D · Siemens AG · 2003K050996 · O-Arm Imaging System · Breakaway Imaging, LLC · 2005 · recalledK060344 · O-Arm Imaging System · Breakaway Imaging, LLC · 2006 · recalledK092564 · O-Arm Imaging System · Medtronic Navigation, Inc. (Littleton) · 2010 · recalledK151000 · O-Arm O2 Imaging System · Medtronic, Inc. · 2015 · recalledK173664 · Medtronic O-arm O2 Imaging System · Medtronic, Inc. · 2017 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 6 generations back: 2 other ancestors, 1 with a Class I recall1 1 generation forward: 3 descendants2 generations forward: 1 descendant, 1 with a Class I recall13 generations forward: 7 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K173664 · Medtronic O-arm O2 Imaging System · Medtronic, Inc. · 2017 · recalledK151000 · O-Arm O2 Imaging System · Medtronic, Inc. · 2015 · recalledK092564 · O-Arm Imaging System · Medtronic Navigation, Inc. (Littleton) · 2010 · recalledK060344 · O-Arm Imaging System · Breakaway Imaging, LLC · 2006 · recalledK050996 · O-Arm Imaging System · Breakaway Imaging, LLC · 2005 · recalledK032280 · Siremobil Iso-C 3D · Siemens AG · 2003K003266 · Siremobil Iso-C 3D · Siemens Medical Solutions USA, Inc. · 2000−50+5
  1. Root · 7 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
  2. 6 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
  3. 5 generations backK050996 O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · Recalled
  4. 4 generations backK060344 O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · Recalled
  5. 3 generations backK092564 O-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton) · 2010 · Recalled
  6. 2 generations backK151000 O-Arm O2 Imaging SystemMedtronic, Inc. · 2015 · Recalled
  7. 1 generation backK173664 Medtronic O-arm O2 Imaging SystemMedtronic, Inc. · 2017 · Recalled
  8. This deviceK200074 O-arm O2 Imaging SystemMedtronic, Inc. · 2020
  9. Descendant · cites it directly · 10 of its ownK210912 Excelsius3DGlobus Medical, Inc. · 2021
  10. Descendant · 2 generations on · 9 of its ownK211616 ExcelsiusHubGlobus Medical, Inc. · 2021 · Recalled (Class I)
  11. Descendant · 3 generations on · 2 of its ownK231850 QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS®…Globus Medical, Inc. · 2024
  12. Descendant · 4 generations on · 1 of its ownK252327 CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025
  13. Descendant · 3 generations on · 1 of its ownK233638 VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2021: 22022: 12024: 62025: 32026: 1
2021high 6 (2024) · low 0 (2023)2026

Class I recalls in this family

  • K003837 Flexiview 8800 Digital Mobile Imaging System6 generations back · 2001
  • K211616 ExcelsiusHub2 generations on · 2021

Most influential descendants

Showing 5 of 13 · See all
  • K210912Excelsius3DGlobus Medical, Inc. · 2021 · cites it directly10descendants
  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 2 generations on9descendants
  • K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc. · 2024 · 3 generations on2descendants
  • K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025 · 4 generations on1descendant
  • K233638VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K003266Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc.2000—
−6K032280Siremobil Iso-C 3DSiemens AG2003—
−5K050996O-Arm Imaging SystemBreakaway Imaging, LLC20054
−4K060344O-Arm Imaging SystemBreakaway Imaging, LLC20061
−3K092564O-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton)201018
−2K151000O-Arm O2 Imaging SystemMedtronic, Inc.20157
−1K173664Medtronic O-arm O2 Imaging SystemMedtronic, Inc.20172
0 (this device)K200074O-arm O2 Imaging SystemMedtronic, Inc.2020—
+1K210912Excelsius3DGlobus Medical, Inc.2021—
+2K211616ExcelsiusHubGlobus Medical, Inc.2021Class I
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.2024—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG2025—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200121

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202121
202210
202460
202530
202610
FIG. 1 — Lineage of K200074, 2000–2026Source: 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.

2 devices in this family have 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 18.2 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K173664Medtronic O-arm O2 Imaging System
Summary page 4
…B Secondary OXO, JAA Classification Name: 892.1650 - Image Intensified Fluoroscopic X-ray System, Mobile Predicate Device: K173664 – O-arm™ O2 Imaging System 4.1.0 software Device Description: The O-arm™ O2 Imaging System is a mobile x-ray system that provid…
Medtronic, Inc.20172

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K210912Excelsius3DGlobus Medical, Inc.202110
K240465O-arm O2 Imaging SystemMedtronic Navigation, Inc.20240
K221230TRONXoran Technologies, LLC20220

Has anything in its family been recalled? (2 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.

  • K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 6 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
  • 7 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K210912 (Globus Medical, Inc., 2021) has gone furthest, with 10 descendants of its own.

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. 2020, this device’s year, is highlighted.

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 O-arm O2 Imaging System is a mobile x-ray system designed for 2D and 3D imaging for adults and pediatric patients weighing 60lbs or greater and having an abdominal thickness greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomical structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.

The O-arm O2 Imaging System in compatible with certain image guided surgery systems.

Indications for use as stated in the FDA summary.

More from Medtronic, Inc.

6,442 FDA decisions under this applicant name. See the company

  • P220026/S019Symplicity G3 Renal Denervation RF GeneratorMedtronic, Inc. · 2026
  • P240036/S007OmniaSecure™ MRI SureScan™ Lead Model 3930MMedtronic, Inc. · 2026
  • P010015/S591Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena…Medtronic, Inc. · 2026
  • P980035/S848Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG…Medtronic, Inc. · 2026
  • P860004/S462SynchroMed™ Infusion System, Ascenda ™ Intrathecal CathetersMedtronic, Inc. · 2026

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/K200074 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200074: O-arm O2 Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200074

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