Observer Ultrasound Reporting and Imaging System
510(k) K022877
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022877 | Date5 Feb 2003 | 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- Withdrawn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
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Observer Ultrasound Reporting and Imaging System is a diagnostic imaging device designed for capturing, storing, and reporting ultrasound images and examination data. It functions as a comprehensive platform for radiologists and obstetrics/gynecology specialists to document findings, generate structured reports, and archive images for future reference. The system integrates imaging acquisition with clinical reporting workflows, ensuring structured and standardized output for patient care.
This system is supplied as a software-based solution for integration with ultrasound equipment, intended for use in clinical radiology departments and obstetrics/gynecology practices. It operates as a reusable, non-sterile device, with no specific regulatory constraints on MRI safety or sterility requirements. The system is authorized under FDA 510(k) clearance (K022877) and is intended for traditional review by the Radiology Advisory Committee. Storage and maintenance follow manufacturer guidelines for software-based medical devices.
Questions
AI-generated answers, 1 Oct 2026
What is the Observer Ultrasound Reporting and Imaging System used for?
The Observer Ultrasound Reporting and Imaging System is designed to capture, store, and generate structured ultrasound reports. It streamlines workflows for radiologists and obstetrics/gynecology specialists by combining imaging acquisition with clinical documentation, ensuring standardized and organized patient records for better care.
How is the Observer system supplied and what type of device is it?
The Observer system is supplied as a software-based solution intended for integration with existing ultrasound equipment. It is a reusable, non-sterile device, meaning it does not require sterilization or single-use compliance. Its functionality relies on software integration rather than physical hardware components.
Is the Observer system approved for specific regulatory pathways?
Yes, the Observer Ultrasound Reporting and Imaging System holds FDA 510(k) clearance under the reference number K022877. It was reviewed by the Radiology Advisory Committee and classified as substantially equivalent to a predicate device, following a traditional review process.
Does the Observer system have any special storage or maintenance requirements?
Storage and maintenance of the Observer system follow manufacturer guidelines for software-based medical devices. Since it is a reusable, non-sterile software solution, it does not require sterile storage or specialized handling beyond standard IT and software maintenance protocols for medical imaging systems.
Can the Observer system be used in MRI environments?
The Observer system does not have specific regulatory constraints related to MRI safety, as it is a software-based solution integrated with ultrasound equipment. However, users should ensure compliance with general MRI safety guidelines when operating in environments where MRI machines are present, particularly regarding electromagnetic interference and equipment compatibility.