SOMATOM Pro.Pulse
by Siemens Medical Solutions USA, Inc.
510(k) K232206
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232206 | Date6 Dec 2023 | 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- Withdrawn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
- JAK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The SOMATOM Pro.Pulse is a dual-source computed tomography (CT) scanner system designed for diagnostic imaging. It delivers high temporal resolution and scan speed to reduce motion artifacts in challenging patients.
The device is supplied as a reusable system for use in clinical radiology settings. It has received FDA 510(k) clearance under K232206 and is authorized for marketing in the United States. The system includes features such as myExam Companion to enhance the scanning experience for users and patients, supported by reliable service solutions and continuous staff education.
Other devices from Siemens Medical Solutions USA, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the SOMATOM Pro.Pulse used for?
The SOMATOM Pro.Pulse is a dual-source computed tomography scanner designed for diagnostic imaging in clinical radiology settings. It provides high temporal resolution and scan speed to reduce motion artifacts in challenging patients.
How is the SOMATOM Pro.Pulse supplied?
The device is supplied as a reusable system for use in clinical radiology settings. It includes features such as myExam Companion to enhance the scanning experience for users and patients.
What regulatory approvals does the SOMATOM Pro.Pulse have?
The SOMATOM Pro.Pulse has received FDA 510(k) clearance under K232206 and is authorized for marketing in the United States. It was reviewed by the Radiology advisory committee.
What support is available for the SOMATOM Pro.Pulse system?
The system is supported by reliable service solutions and continuous staff education to ensure optimal performance and user experience in clinical settings.