510(k) Report

510(k) · Cleared

Cleared

3D Navigation Interface for Siremobile Iso-C 3D

K022337510(k) SpecialCleared Aug 13, 200226-day reviewClass II21 CFR 892.1720

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

Siemens Medical Solutions USA, Inc. · IZL System, X-Ray, Mobile

Cleared on Aug 13, 2002 as substantially equivalent to K973598 (Siemens Medical Solutions USA, Inc., 1997) and 1 other predicate after a 26-day review. Its family tree reaches back 1 generation to 1997. 22 later devices descend from it.

Decided
Aug 13, 2002
Review
26 days
Class
Class II
Product code
IZL
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K973598 (1997). 2 ancestors in all. 22 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2004: 1 descendant cleared2018: 1 descendant cleared2021: 4 descendants cleared2020: 1 descendant cleared2022: 3 descendants cleared2023: 1 descendant cleared2025: 5 descendants cleared2024: 2 descendants cleared2026: 4 descendants clearedK973598 · Siremobil CO2 · Siemens Medical Solutions USA, Inc. · 1997 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 6 descendants4 generations forward: 8 descendants5 generations forward: 4 descendants6 generations forward: 1 descendant K973598 · Siremobil CO2 · Siemens Medical Solutions USA, Inc. · 1997 · recalled0+5
  1. Root · 1 generation backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
  2. This deviceK022337 3D Navigation Interface for Siremobile Iso-C 3DSiemens Medical Solutions USA, Inc. · 2002
  3. Descendant · cites it directly · 21 of its ownK042793 Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Siemens Medi Cal Solutions, Inc. · 2004 · Recalled
  4. Descendant · 2 generations on · 10 of its ownK181550 Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · Recalled
  5. Descendant · 2 generations on · 9 of its ownK202547 Surgivisio systemSurgivisio · 2021
  6. Descendant · 3 generations on · 9 of its ownK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
  7. Descendant · 3 generations on · 8 of its ownK220627 SURGIVISIO DeviceEcential Robotics · 2022

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2004: 12018: 12020: 12021: 42022: 32023: 12024: 22025: 52026: 4
2004high 5 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 22 · See all
  • K042793Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Siemens Medi Cal Solutions, Inc. · 2004 · cites it directly21descendants
  • K181550Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on10descendants
  • K202547Surgivisio systemSurgivisio · 2021 · 2 generations on9descendants
  • K203504Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · 3 generations on9descendants
  • K220627SURGIVISIO DeviceEcential Robotics · 2022 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K973598Siremobil CO2Siemens Medical Solutions USA, Inc.19971
0 (this device)K0223373D Navigation Interface for Siremobile Iso-C 3DSiemens Medical Solutions USA, Inc.2002—
+1K042793Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Siemens Medi Cal Solutions, Inc.20042
+2K181550Cios SpinSiemens Medical Solutions USA, Inc.20184
+2K202547Surgivisio systemSurgivisio2021—
+3K203504Cios FlowSiemens Medical Solutions USA, Inc.20201
+3K220627SURGIVISIO DeviceEcential Robotics2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201810
202010
202140
202230
202310
202420
202550
202640
FIG. 1 — Lineage of K022337, 1997–2026Source: 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 IZL? 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 IZL device

  1. #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K973598Siremobil CO2
Summary page 1
…~ Predicate Device Nume FDA Clearance Number FDA Clearance Date Siemens Siremobil Iso-C K97 3598 11/10/1997 Siemens Siremobil Iso-C 3D KO03266 1 2/0 1/2000 4. Device…
Siemens Medical Solutions USA, Inc.19971
*K003266Siremobil Iso-C 3D
Summary page 2
…Predicate: The 3D Navigation Interface option does not alter the fundamental scientific technology of the predicate device, Siremobil Iso-C 3D (K003266). The 3D- navigation interface transfers 3D-image data sets acquired with the Siremobil Iso-C 3D and the naviga…
Siemens Medical Solutions USA, Inc.2000—

Also cleared against K973598: 6 other devices →

What descends from it? (22)

See all 22

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042793Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Siemens Medi Cal Solutions, Inc.200421

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K042793 (Siemens Medi Cal Solutions, Inc., 2004) has gone furthest, with 21 descendants of its own.
  • 6 other devices also cite its predicate K973598.

How does its category compare?

All IZL devices

IZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IZL

11in 2025

2007: 32008: 42009: 32010: 32011: 62012: 32014: 72015: 42016: 62017: 72018: 82019: 92020: 92021: 132022: 162023: 32024: 92025: 112026 (partial year): 6
2007high 16 (2022) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZL

153in 2025

2007: 30 days median2008: 49 days median2009: 125 days median2010: 65 days median2011: 66 days median2012: 83 days median2014: 104 days median2015: 88 days median2016: 47 days median2017: 45 days median2018: 47 days median2019: 33 days median2020: 43 days median2021: 48 days median2022: 89 days median2023: 55 days median2024: 159 days median2025: 153 days median2026 (partial year): 157 days median
2007high 159 (2024) · low 30 (2007)2026

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

Recalls per year · IZL

47in 2025

2007: 72010: 42011: 62012: 52013: 102014: 42015: 42019: 22020: 12022: 12023: 62024: 52025: 472026 (partial year): 5
2007high 47 (2025) · low 0 (2008)2026

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

Adverse event reports per year · IZL

27in 2025

2007: 162008: 272009: 352010: 752011: 1182012: 242013: 172014: 512015: 302016: 332017: 352018: 272019: 402020: 482021: 472022: 322023: 772024: 392025: 27
2007high 118 (2011) · low 16 (2007)2025

MAUDE reports naming product code IZL, 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
2007330716
2008449027
20093125035
2010365475
20116666118
2012383524
20130—1017
20147104451
2015488430
2016647033
2017745035
2018847027
2019933240
2020943148
20211348047
20221689132
2023355677
20249159539
2025111534727
202661575—

What is it indicated for?

The Siremobil Iso-C 3D with the 3D Navigation Interface option is based on Siemens isocentric mobile C-arm, marketed as Siremobil Iso-C. The 3D imaging option of the Siremobil Iso-C 3D contains hardware for the motorized movement of the orbital axis, a 3D workstation and a software package for volume reconstruction from two-dimensional images, 3D post-processing and visualization. The Siremobil Iso-C 3D with the 3D Navigation Interface option is intended…

Read the full statement (132 words)

The Siremobil Iso-C 3D with the 3D Navigation Interface option is based on Siemens isocentric mobile C-arm, marketed as Siremobil Iso-C. The 3D imaging option of the Siremobil Iso-C 3D contains hardware for the motorized movement of the orbital axis, a 3D workstation and a software package for volume reconstruction from two-dimensional images, 3D post-processing and visualization.

The Siremobil Iso-C 3D with the 3D Navigation Interface option is intended to be used whenever the surgeon benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures (e.g. bones and joints). The Siremobil Iso-C 3D with the 3D Navigation Interface option is designed as a 3D imaging device for conditions such as complex bone or joint fractures of the upper and lower extremities (including knee, foot, elbow, hand), and the spine.

Indications for use as stated in the FDA summary.

Also cleared against K973598

6 other devices cite the same predicate.

  • K042793Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Siemens Medi Cal Solutions, Inc. · 20042 recalls
  • K040675Axiom Artis USiemens Medical Systems, Inc. · 20041 recall
  • K032761KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc. · 2004
  • K040066Siremobile C06Siemens Medical Solutions USA, Inc. · 20042 recalls
  • K0304503D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
  • K022114ImperiumElmstech, Inc. · 2002

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798 FDA decisions under this applicant name. See the company

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The IZL category page

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https://510kreport.com/device/K022337 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022337: 3D Navigation Interface for Siremobile Iso-C 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022337

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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