Medstreaming Medical Office Software
510(k) K072972
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072972 | Date6 Nov 2007 | 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- Withdrawn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 Medstreaming Medical Office Software is a radiology information system designed to manage and streamline workflows for medical offices, particularly those specializing in image-intensive specialties. It integrates diagnostic imaging data, patient records, and administrative functions to enhance clinical decision-making and operational efficiency. As classified under product code LLZ, it supports the organization and retrieval of radiology-related information in a structured digital environment.
This software is supplied as a traditional software solution for medical offices, intended for use in clinical settings where radiology and diagnostic imaging are integral to patient care. It is not a medical device in the traditional sense but has undergone FDA 510(k) clearance (K072972) under the Radiology Advisory Committee, confirming its regulatory compliance for use in healthcare environments. The system is not single-use or reusable in the physical sense but is deployed as a digital platform requiring appropriate IT infrastructure and maintenance. No sterility or MRI safety considerations apply, as it operates as a software application.
Questions
AI-generated answers, 1 Oct 2026
What is the Medstreaming Medical Office Software used for?
The Medstreaming Medical Office Software is designed as a radiology information system to manage and streamline workflows in medical offices, particularly those specializing in image-intensive specialties like radiology or diagnostic imaging. It integrates diagnostic imaging data with patient records and administrative functions, helping clinicians organize and retrieve radiology-related information efficiently. This reduces manual processes and supports better clinical decision-making by providing a centralized digital platform for all relevant data.
How is the Medstreaming Medical Office Software supplied and deployed?
The software is supplied as a traditional digital platform, meaning it requires installation on a compatible IT infrastructure within the medical office. Unlike physical medical devices, it is not single-use or reusable in a physical sense—it is deployed as a software solution that must be maintained and updated by the office’s IT team. No hardware or physical components are involved; the system operates entirely within the office’s existing network and hardware setup.
Is the Medstreaming Medical Office Software sterile or subject to MRI safety considerations?
No, the Medstreaming Medical Office Software is not a physical device and therefore does not require sterility or MRI safety considerations. As a software application, it operates independently of physical environments like operating rooms or MRI machines. The system’s compliance is based on its regulatory clearance for use in healthcare settings, not on physical safety standards.
What regulatory clearance does the Medstreaming Medical Office Software hold?
The Medstreaming Medical Office Software has undergone FDA 510(k) clearance under the Radiology Advisory Committee, with clearance number K072972. This clearance confirms its substantial equivalence to a predicate device and its compliance for use in healthcare environments where radiology and diagnostic imaging are integral to patient care. The classification under product code LLZ further supports its role as a radiology information system.
Can the Medstreaming Medical Office Software be used across different medical specialties?
While the Medstreaming Medical Office Software is specifically designed for medical offices with radiology and diagnostic imaging needs, its core functionality—integrating imaging data with patient records—can support workflows in image-intensive specialties. However, its primary optimization is for environments where radiology is central to clinical operations. Offices should evaluate whether the software’s features align with their specific specialty requirements before deployment.