Sigma 5000 Series Imagic Ultrasound System
by Kontron Medical Systems Sas 2 variants
510(k) K053084
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053084 | Date16 Nov 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Sigma 5000 Series Imagic Ultrasound System is a mobile diagnostic ultrasound device designed for real-time imaging and Doppler studies. It operates using various transducers to generate B-mode, M-mode, pulsed-wave/continuous-wave Doppler, Color Flow Mapping, and Color Time Motion imaging. This system is classified as an ultrasound imaging system, enabling clinicians to visualize internal body structures and blood flow for diagnostic purposes.
The device is intended for use in clinical settings by trained clinicians and is supplied as a mobile console measuring approximately 60×95×130 cm, featuring a TFT screen and keyboard control panel. It is not described as single-use or reusable in the provided data, nor are there explicit details on sterility or MRI safety. The system holds an FDA 510(k) clearance under K-number K053084, with a traditional review process through the Radiology Advisory Committee. No additional regulatory or supply-specific details are provided beyond the clearance status.
Other devices from Kontron Medical Systems Sas
Questions
AI-generated answers, 1 Oct 2026
What imaging capabilities does the Sigma 5000 Series Imagic Ultrasound System provide?
The Sigma 5000 Series Imagic Ultrasound System delivers real-time imaging through multiple modalities, including B-mode for structural visualization, M-mode for motion assessment, pulsed-wave/continuous-wave Doppler for blood flow velocity measurement, and Color Flow Mapping/Color Time Motion for dynamic blood flow visualization. These features enable comprehensive diagnostic evaluations of internal organs and vascular structures.
How is the Sigma 5000 Series Imagic Ultrasound System supplied and what are its dimensions?
The system is supplied as a mobile console designed for clinical use. It measures approximately 60×95×130 cm and includes a TFT screen and keyboard control panel, allowing for portability and ease of operation in various healthcare settings.
Is the Sigma 5000 Series Imagic Ultrasound System intended for single-use or reusable applications?
The provided data does not specify whether the Sigma 5000 Series Imagic Ultrasound System is intended for single-use or reusable applications. However, as a mobile diagnostic device, it is typically designed for repeated use in clinical environments with appropriate cleaning and maintenance protocols.
What regulatory clearance does the Sigma 5000 Series Imagic Ultrasound System hold?
The Sigma 5000 Series Imagic Ultrasound System holds FDA 510(k) clearance under the K-number K053084. The clearance was determined through a traditional review process involving the Radiology Advisory Committee, confirming its substantial equivalence to a predicate device.
Can the Sigma 5000 Series Imagic Ultrasound System be used in MRI environments?
The provided data does not include explicit details regarding MRI safety for the Sigma 5000 Series Imagic Ultrasound System. Clinicians should consult manufacturer guidelines or safety documentation to ensure compatibility with MRI environments before use.