510(k) Report

510(k) · Cleared

Recalled · 2005

Siremobil CO2

K973598510(k) TraditionalCleared Nov 10, 199749-day reviewClass II21 CFR 892.1650Recalls 1

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. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile

Cleared on Nov 10, 1997 after a 49-day review. The FDA summary names no predicate by number. 168 later devices descend from it. It has been recalled once.

Decided
Nov 10, 1997
Review
49 days
Class
Class II
Product code
OXO
Recalls
1
Predicates
0

168 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2004: 4 descendants cleared2002: 2 descendants cleared2003: 2 descendants cleared2005: 3 descendants cleared2007: 4 descendants cleared2006: 4 descendants cleared2008: 5 descendants cleared2020: 9 descendants cleared2016: 12 descendants cleared2017: 5 descendants cleared2014: 4 descendants cleared2011: 6 descendants cleared2018: 16 descendants cleared2021: 17 descendants cleared2012: 4 descendants cleared2013: 9 descendants cleared2010: 3 descendants cleared2019: 8 descendants cleared2022: 7 descendants cleared2023: 9 descendants cleared2015: 2 descendants cleared2025: 15 descendants cleared2026: 13 descendants cleared2024: 5 descendants cleared1995200020052010201520202025
  1. This deviceK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997
  2. Descendant · cites it directly · 88 of its ownK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
  3. Descendant · 2 generations on · 66 of its ownK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
  4. Descendant · 3 generations on · 61 of its ownK060328 Planmeca Promax 3DPlanmeca Oy · 2006
  5. Descendant · cites it directly · 49 of its ownK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
  6. Descendant · 2 generations on · 31 of its ownK061284 I-Cat ScannerImaging Sciences Intl., Inc. · 2006 · Recalled

Showing 5 of 168 descendants. See all descendants

Descendants cleared per year

2002: 22003: 22004: 42005: 32006: 42007: 42008: 52010: 32011: 62012: 42013: 92014: 42015: 22016: 122017: 52018: 162019: 82020: 92021: 172022: 72023: 92024: 52025: 152026: 13
2002high 17 (2021) · low 0 (2009)2026

Most influential descendants

Showing 5 of 168 · See all
  • K0304503D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003 · cites it directly88descendants
  • K0525873D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005 · 2 generations on66descendants
  • K060328Planmeca Promax 3DPlanmeca Oy · 2006 · 3 generations on61descendants
  • K040675Axiom Artis USiemens Medical Systems, Inc. · 2004 · cites it directly49descendants
  • K061284I-Cat ScannerImaging Sciences Intl., Inc. · 2006 · 2 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973598Siremobil CO2Siemens Medical Solutions USA, Inc.1997—
+1K0304503D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc.2003—
+2K0525873D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc.2005—
+3K060328Planmeca Promax 3DPlanmeca Oy2006—
+1K040675Axiom Artis USiemens Medical Systems, Inc.20041
+2K061284I-Cat ScannerImaging Sciences Intl., Inc.20062

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200320
200440
200530
200640
200740
200850
201030
201160
201240
201390
201440
201520
2016120
201750
2018160
201980
202090
2021170
202270
202390
202450
2025150
2026130
FIG. 1 — Lineage of K973598, 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 OXO? 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 OXO device

  1. #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 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?

The FDA summary names no predicate by number.

What descends from it? (168)

See all 168

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

NumberDeviceApplicantDecidedDescendants
K0304503D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc.200388
K040675Axiom Artis USiemens Medical Systems, Inc.200449
K0223373D Navigation Interface for Siremobile Iso-C 3DSiemens Medical Solutions USA, Inc.200222
K042793Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Siemens Medi Cal Solutions, Inc.200421
K040066Siremobile C06Siemens Medical Solutions USA, Inc.200421
K022114ImperiumElmstech, Inc.200215
K032761KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc.200414

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 1, 2005Not classifiedZ-0123-06OtherScrews may become loose and fall into the OR field during surgery.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K030450 (J. Morita USA, Inc., 2003) has gone furthest, with 88 descendants of its own.

How does its category compare?

All OXO devices

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

FDA decisions per year · OXO

4in 2025

2010: 12012: 42013: 22014: 22015: 12016: 32017: 42018: 12019: 32021: 22024: 22025: 42026 (partial year): 2
2007high 4 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OXO

97in 2025

2012: 48 days median2016: 128 days median2017: 57 days median2019: 213 days median2025: 97 days median
2007high 213 (2019) · low 48 (2012)2026

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

Recalls per year · OXO

4in 2024

2012: 42013: 32014: 42016: 32017: 42018: 112024: 42026 (partial year): 1
2007high 11 (2018) · low 0 (2007)2026

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

Adverse event reports per year · OXO

118in 2025

2012: 52013: 412014: 892015: 972016: 3,8202017: 1,6972018: 1,6472019: 1,2972020: 8162021: 5542022: 2952023: 2752024: 1922025: 118
2007high 3,820 (2016) · low 0 (2007)2025

MAUDE reports naming product code OXO, 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
20070—00
20080—00
20090—00
20101—00
20110—00
201244845
20132—341
20142—489
20151—097
2016312833,820
201745741,697
20181—111,647
2019321301,297
20200—0816
20212—0554
20220—0295
20230—0275
20242—4192
20254970118
20262—1—

What is it indicated for?

The Siremobil C02 is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Siremobil C02 can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of mtra—medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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Recent decisions in OXO

The OXO category page

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  • K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026
  • K253269OEC One CFDGe Hualun Medical Systems Co., Ltd. · 2025
  • K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd. · 2025
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https://510kreport.com/device/K973598 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973598: Siremobil CO2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973598

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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