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Siremobile C06

by Siemens Medical Solutions USA, Inc.

510(k) K040066

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK040066 Date12 Feb 2004ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0439-06 FDA Unclassified (pre-2012) initiated 12 Dec 2005 on shared 510(k) K040066

    patient information can be stored in another patient's file.

    • Terminated Z-0119-06 FDA Unclassified (pre-2012) initiated 1 Aug 2005 on shared 510(k) K040066

    Screws may become loose and fall into the OR field during surgery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OXO
Device class
Class II
Regulation
21 CFR Part 892.1650
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Siremobile C06 is an Image-Intensified Fluoroscopic X-Ray System, Mobile, designed for real-time radiographic imaging. It employs an image-intensifier tube to amplify X-ray signals, enabling high-contrast visualization of internal structures during fluoroscopic procedures. This mobile system is engineered for versatility in radiology settings, supporting procedures such as angiography, cardiology, and orthopedic interventions. Its portability allows deployment across various clinical environments, including operating rooms and interventional suites.

The Siremobile C06 is supplied as a reusable medical device, intended for use in controlled clinical settings with appropriate sterilization protocols. It operates within Class II regulatory classification under 21 CFR 892.1650 and holds FDA 510(k) clearance (K040066) as substantially equivalent to predicate devices. Compatibility with MRI environments is not specified, and its design adheres to safety standards for fluoroscopic imaging systems. Storage and maintenance require adherence to manufacturer guidelines to ensure operational integrity and patient safety.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical procedures is the Siremobile C06 designed to support?

    The Siremobile C06 is engineered for real-time radiographic imaging during fluoroscopic procedures, making it suitable for specialized interventions such as angiography, cardiology studies, and orthopedic surgeries. Its image-intensifier tube amplifies X-ray signals to provide high-contrast visualization of internal structures, ensuring precise guidance during these procedures.

  • How is the Siremobile C06 supplied and maintained?

    The Siremobile C06 is a reusable medical device intended for use in controlled clinical environments. Proper sterilization protocols must be followed to maintain hygiene and functionality. Adherence to the manufacturer’s guidelines for storage and maintenance is critical to ensure operational integrity, patient safety, and compliance with regulatory standards.

  • Is the Siremobile C06 compatible with MRI environments?

    The Siremobile C06’s compatibility with MRI environments is not specified in the available documentation. Clinicians should consult the manufacturer’s instructions and local safety protocols before using this device in proximity to MRI systems to avoid potential interference or safety risks.

  • What regulatory classification and clearance does the Siremobile C06 hold?

    The Siremobile C06 is classified under Class II of the FDA’s regulatory framework (21 CFR 892.1650) and holds FDA 510(k) clearance (K040066). This clearance confirms it is substantially equivalent to predicate devices, ensuring it meets established safety and performance standards for fluoroscopic imaging systems.

  • Where can the Siremobile C06 be deployed, and what are its key features?

    The Siremobile C06 is a portable fluoroscopic X-ray system designed for versatility across clinical environments, including operating rooms, interventional suites, and radiology departments. Its portability, combined with the image-intensifier technology, enables high-contrast imaging for procedures requiring real-time visualization, such as vascular studies and orthopedic interventions.