DynaCT

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K042646 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Omnia X/Xs Ultrasound System

  Class II

  FDA 510(k) K020353 Active Cleared 13 Feb 2002

• Somatom Project P30L

  Class II

  FDA 510(k) K040577 Active Cleared 22 Mar 2004

• 6 Channel Body Coil

  Class II

  FDA 510(k) K023571 Active Cleared 20 Nov 2002

• Somatom Spirit

  Class II

  FDA 510(k) K042328 Active Cleared 14 Sep 2004

• Somatom P30 CT Systems

  Class II

  FDA 510(k) K013522 Active Cleared 7 Nov 2001

• Somatom Definition Edge

  Class II

  FDA 510(k) K120579 Active Cleared 23 May 2012

See all devices from Siemens Medical Systems USA, Inc. →

• What types of procedures can the DynaCT support during real-time imaging, and why is this important for clinicians?

  The DynaCT is designed for intra-procedural imaging in hybrid operating rooms or angiography suites, combining X-ray angiography with volumetric CT to provide high-resolution, three-dimensional visualization. This is critical for clinicians performing interventions like vascular procedures, biopsies, or tumor ablations, as it allows immediate verification of treatment outcomes without requiring patient transfer. The real-time imaging ensures precision and reduces procedural risks by confirming placement or effects during the procedure itself.

• Is the DynaCT system reusable, and what maintenance or sterilization steps are required?

  Yes, the DynaCT is supplied as a reusable system, meaning it is designed for repeated use in clinical settings. Proper sterilization and maintenance are mandatory per the manufacturer’s guidelines to ensure safety and performance. Since it operates in sterile environments like hybrid ORs or angiography suites, adherence to these protocols is essential to prevent contamination and maintain imaging accuracy.

• What are the key safety considerations for using the DynaCT in a clinical setting, particularly regarding MRI compatibility?

  The DynaCT is MRI-safe for its designated use, meaning it can be operated in environments where MRI systems are present without interfering with their function. However, this does not imply it is safe for use inside an MRI scanner or for all MRI-related applications. Clinicians should strictly follow the manufacturer’s guidelines for spatial and operational compatibility to ensure patient and staff safety, especially in hybrid rooms where both imaging modalities may be present.

• How does the DynaCT’s regulatory clearance impact its use in radiology departments?

  The DynaCT holds FDA 510(k) clearance (K042646) as a Class II medical device, indicating it meets regulatory standards for safety and effectiveness in interventional radiology applications. This clearance confirms its substantial equivalence to a predicate device, allowing radiology departments to integrate it into their workflows with confidence. However, departments should verify compliance with the manufacturer’s instructions and institutional protocols to ensure proper use and maintenance.