Multigraph X-Ray Tomographic System

• • Terminated Z-0987-03 FDA Unclassified (pre-2012) ·initiated 15 Apr 2003

  the back up safety catch may not function properly

Full name

Multigraph

510(k) Number

K790765 ↗

FDA Product Code

IZF

Device Class

Class II

Regulation

21 CFR Part 892.1740

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Siemens Corp. →

• What is the Multigraph X-Ray Tomographic System used for?

  The Multigraph is designed for tomographic imaging in radiology, enabling detailed cross-sectional visualization of anatomical structures using X-ray technology. This capability is critical for clinical assessments where precise imaging is required, such as evaluating complex anatomical areas or planning surgical interventions.

• Is the Multigraph a single-use or reusable device?

  The Multigraph is supplied as a reusable medical device. It is intended for long-term use within radiology departments, allowing for repeated imaging procedures without disposal after each use. Reusability aligns with its classification as a Class II device, which typically includes equipment designed for durable clinical applications.

• What regulatory clearance does the Multigraph hold?

  The Multigraph holds FDA clearance under the 510(k) premarket notification process, specifically clearance number K790765. This clearance was granted in 1979 and remains active, confirming its compliance with FDA regulations for Class II medical devices in the category of System, X-Ray, Tomographic (product code IZF). The device was reviewed by the Radiology Advisory Committee.

• Are there multiple models or sizes of the Multigraph?

  The regulatory data lists multiple registration numbers associated with the Multigraph, which may correspond to different installations or configurations rather than distinct models or sizes. However, no specific details on variations in size, model differentiation, or technical specifications beyond the core system are provided in the available documentation.

• How should the Multigraph be stored?

  The regulatory data does not specify storage conditions for the Multigraph. As a reusable medical device, proper storage would typically involve following manufacturer guidelines for environmental control (e.g., temperature, humidity) to ensure operational integrity and prevent contamination. Clinicians should consult Siemens Corp.’s operational manuals for detailed storage instructions.