R4 Acert Ultrasound Reporting System
by R4, LLC 510(k)
Active
510(k) K101898
Overview
The R4 Acert Ultrasound Reporting System is a medical image management and processing system. It provides capabilities for the review and digital processing of medical images to assist trained practitioners with disease detection, diagnosis, and patient management.
This device is identified by FDA 510(k) number K101898 and is classified under the radiology medical specialty. It received a decision of substantially equivalent on September 15, 2011.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101898 | Date15 Sep 2011 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the primary function of the R4 Acert Ultrasound Reporting System?
The system is designed as a medical image management and processing tool. It enables trained practitioners to review and digitally process medical images to support disease detection, clinical diagnosis, and patient management.
What is the regulatory status of this reporting system?
The R4 Acert Ultrasound Reporting System is authorized via FDA 510(k) clearance, identified by submission number K101898. It received a decision of substantially equivalent on September 15, 2011, and is classified under the radiology medical specialty.
Who is the manufacturer of the R4 Acert system?
The system is manufactured by R4, LLC, which is based in Strongsville, Ohio. The device is categorized under the radiology advisory committee for its image processing and management capabilities.