MobiUS Ultrasound Imaging System
510(k) K102153
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102153 | Date20 Jan 2011 | 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- Withdrawn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
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The MobiUS Ultrasound Imaging System is a portable diagnostic device classified as an ultrasound imaging system. It generates real-time visual images of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and fluid collections for diagnostic purposes.
This system is designed for use in clinical settings, including point-of-care environments, where compact size and ease of operation are critical. Supplied as a reusable device, it requires proper sterilization protocols between uses. Authorized under FDA 510(k) clearance (K102153), it adheres to regulatory standards for medical imaging equipment and is intended for professional healthcare use only.
Questions
AI-generated answers, 19 Sep 2026
Is the MobiUS Ultrasound Imaging System designed for single-use or can it be reused in a clinical setting?
The MobiUS Ultrasound Imaging System is a reusable device, meaning it is intended for multiple uses in clinical settings. However, since it is reusable, it must be properly sterilized between uses to maintain safety and hygiene standards. This design makes it suitable for environments where portability and repeated use are important, such as point-of-care settings.
What types of internal structures can the MobiUS Ultrasound Imaging System visualize, and how does it help clinicians?
The MobiUS Ultrasound Imaging System generates real-time images of internal body structures using high-frequency sound waves, allowing clinicians to assess organs, tissues, and fluid collections. This capability supports diagnostic evaluations by providing visual insights into anatomical features, aiding in the identification of abnormalities or conditions that may require further medical attention.
How is the MobiUS Ultrasound Imaging System different from traditional ultrasound machines in terms of portability and intended use?
The MobiUS Ultrasound Imaging System is specifically designed as a portable diagnostic device, prioritizing compact size and ease of operation for clinical settings, including point-of-care environments. Unlike larger, stationary ultrasound machines, its portability allows for greater flexibility in patient care, enabling clinicians to perform imaging at the bedside or in areas where traditional equipment may not be practical.
What regulatory pathway was followed for the FDA clearance of the MobiUS Ultrasound Imaging System, and what does this mean for its use?
The MobiUS Ultrasound Imaging System received FDA clearance through a 510(k) pathway, specifically under the Traditional clearance type with a Substantially Equivalent determination. This means the device was evaluated by the FDA as meeting the same performance criteria as a legally marketed predicate device, ensuring it adheres to regulatory standards for medical imaging equipment. It is authorized for professional healthcare use only, as outlined in the clearance documentation.