Ysio Max
by Siemens Medi Cal Solutions, Inc. 510(k)
Active
510(k) K181279
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181279 | Date13 Jun 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KPR
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Ysio Max is a stationary X-ray system designed for radiography. It is classified as a Class II medical device and functions as a digital radiography system, enabling high-quality imaging for diagnostic purposes in radiology settings.
This system is intended for use in radiology departments and is supplied as a reusable, non-sterile device. It is compatible with MRI environments as indicated by its regulatory classification and is available in configurations supported by firmware versions VF10 and higher. The Ysio Max adheres to FDA 510(k) clearance under Special Review (K181279) and is regulated under the Federal Food, Drug, and Cosmetic Act (21 CFR 892.1680).
Other devices from Siemens Medi Cal Solutions, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of imaging tasks is the Ysio Max designed to support in a radiology department?
The Ysio Max is a stationary X-ray system specifically designed for digital radiography, enabling high-quality imaging for diagnostic purposes in radiology settings. It is intended for general radiographic procedures, including but not limited to standard X-ray imaging, where precise and clear images are required for accurate medical assessment.
Is the Ysio Max compatible with MRI environments, and how does this affect its use?
Yes, the Ysio Max is explicitly noted as compatible with MRI environments, as indicated by its regulatory classification. This means it can be safely used in facilities where MRI machines are present, reducing the need for separate imaging equipment and streamlining workflows in multi-modality departments.
How is the Ysio Max supplied, and what does this mean for its maintenance and reuse?
The Ysio Max is supplied as a reusable, non-sterile device. This means it is designed for repeated use within a radiology department after proper cleaning and maintenance, rather than being single-use or requiring sterilization between patients. Reusability helps reduce costs and waste while ensuring consistent performance.
What firmware versions are supported by the Ysio Max, and why might this matter to a buyer?
The Ysio Max is compatible with firmware versions VF10 and higher. This matters to buyers because newer firmware versions may include updated features, improved imaging quality, enhanced compatibility with other systems, or security patches, ensuring the device remains current and functional over time.
What regulatory pathway was followed for the Ysio Max, and what does this indicate about its safety and compliance?
The Ysio Max underwent FDA 510(k) clearance under Special Review (K181279), classified as substantially equivalent to a predicate device. This indicates that the FDA reviewed its safety and effectiveness, confirming it meets regulatory standards for use in radiology. The Special Review designation suggests additional scrutiny, which often implies a higher level of confidence in its compliance and performance.