Identifiers
- 510(k) Number
- K000571 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The GE Logiq 700 is a diagnostic ultrasound system, designed for imaging internal body structures using high-frequency sound waves. It is classified under the product code IYO and is intended for radiologic examination, enabling real-time visualization of organs, tissues, and blood flow for diagnostic purposes.
This device is supplied as a reusable medical instrument, intended for use in clinical radiology settings. It is not described as sterile or single-use, and MRI safety information is not specified in the provided data. The system was cleared by the FDA under 510(k) number K000571, with a decision date of April 18, 2000, and falls under the Radiology Advisory Committee’s review.
Frequently asked questions
Is the GE Logiq 700 designed for single-use or can it be reused in clinical settings?
The GE Logiq 700 is explicitly described as a reusable medical instrument, intended for use in clinical radiology settings. Since it is not labeled as single-use or sterile, it must be properly cleaned, disinfected, and maintained between uses to ensure safety and functionality. Always follow manufacturer guidelines for reprocessing.
What types of diagnostic imaging can the GE Logiq 700 perform, and what makes it suitable for radiologic examinations?
The GE Logiq 700 is a diagnostic ultrasound system that uses high-frequency sound waves to visualize internal body structures in real time. It is designed for radiologic examinations, allowing clinicians to assess organs, tissues, and blood flow—key features for applications like obstetrics, cardiology, abdominal imaging, and musculoskeletal evaluations. Its classification under product code IYO (Radiology) confirms its role in diagnostic imaging.
How is the GE Logiq 700 regulated in the U.S., and which committee reviewed its submission?
The GE Logiq 700 was cleared by the FDA under a 510(k) submission (K000571) with a Special clearance type, determined to be *substantially equivalent* to a predicate device. The submission was reviewed by the Radiology Advisory Committee (RA) and filed in Milwaukee, WI, on February 22, 2000, with a decision date of April 18, 2000. This route confirms its regulatory classification as a radiologic diagnostic device.
What clinical settings is the GE Logiq 700 intended for, and how does its reusable nature impact its use?
The GE Logiq 700 is intended for clinical radiology settings, where reusable diagnostic equipment is standard. As a reusable device, it requires proper maintenance protocols—including cleaning, disinfection, and calibration—to ensure reliability and patient safety across multiple procedures. Its design supports long-term use in hospitals, imaging centers, or outpatient clinics where ultrasound diagnostics are performed regularly.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GE LOGIQ 700 Service Manual: Technical Publication, GE Medical Systems LOGIQ 700 Service Manual | Manualzz, Ge Medical Systems Manuals & User Guides - Manuals+, PDF GE Medical Systems LOGIQ 700 Service Manual - iFixit, GE Medical Systems LOGIQ 700 Ultrasound Quick Start Guide
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K000571 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ge Medical Systems
Sources (1)
- FDA 510(k) K000571 24 fields · synced Oct 6, 2026