Siemens Sireskop 4

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K820111 ↗

FDA Product Code

KXJ

Device Class

Class II

Regulation

21 CFR Part 892.1980

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K123375 Active Cleared 20 Nov 2012

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  Class II

  FDA 510(k) K781286 Active Cleared 11 Sep 1978

• Siemens Polydoros 800

  Class I

  FDA 510(k) K820112 Active Cleared 24 Feb 1982

• Opti 110/12/50HSG

  Class I

  FDA 510(k) K810190 Active Cleared 2 Mar 1981

• Optiplanimat

  Class II

  FDA 510(k) K781531 Active Cleared 14 Sep 1978

• Somatom 2

  Class II

  FDA 510(k) K790975 Active Cleared 30 Jul 1979

See all devices from Siemens Corp. →

• What is the primary purpose of the Siemens Sireskop 4 in a clinical setting?

  The Siemens Sireskop 4 is a radiologic table designed specifically for fluoroscopic imaging, allowing radiologists to visualize internal structures in real-time during diagnostic procedures. It provides stable patient support to ensure accurate and clear imaging during fluoroscopy, which is essential for procedures requiring continuous X-ray visualization, such as endoscopy or orthopedic assessments.

• Is the Siemens Sireskop 4 intended for single-use or reusable applications?

  The Siemens Sireskop 4 is supplied as a reusable medical instrument, meaning it is designed for repeated use in radiology departments after proper cleaning and maintenance. It is not sterile upon delivery, so facilities must follow manufacturer guidelines for decontamination and sterilization before each use.

• What regulatory pathway does the Siemens Sireskop 4 follow, and how does this affect its use?

  The Siemens Sireskop 4 is authorized under the FDA’s 510(k) clearance process (K820111) and classified as a Class II device under regulation number 892.1980. This means it has undergone a premarket submission to demonstrate substantial equivalence to a predicate device, ensuring it meets FDA safety and effectiveness standards for radiologic tables. Clinicians can rely on this regulatory clearance as part of their due diligence when integrating the device into their workflow.

• Does the Siemens Sireskop 4 come with any specific safety considerations, such as MRI compatibility?

  The Siemens Sireskop 4 is not specified as MRI-safe in the provided data, meaning it should not be used in MRI environments unless explicitly verified by the manufacturer for compatibility. Clinicians must confirm its suitability for their specific imaging modalities and follow all manufacturer guidelines to avoid interference or safety risks.

• How many registration numbers are associated with the Siemens Sireskop 4, and what do they indicate?

  The Siemens Sireskop 4 has multiple registration numbers (e.g., 9613183, 3003768277, etc.), which are part of the U.S. regulatory tracking system to ensure compliance and traceability. These numbers confirm the device’s compliance with FDA requirements and help track its distribution and usage within healthcare facilities. They do not indicate clinical functionality but serve administrative purposes for regulatory oversight.