Ge Logiq BT08 Diagnostic Ultrasound System
by Ge Medical Systems Ultrasound and Primary Care Dia 510(k)
Active
510(k) K073408
Overview
The GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM is a full-featured, general purpose diagnostic ultrasound system. It consists of a mobile console approximately 58 cm deep and 141 cm high that provides digital acquisition, processing, and display capability.
The system includes a computer keyboard, specialized controls, a 10-inch LCD touch screen, and a color 19-inch LCD image display. It is supplied as a mobile console unit and was cleared via FDA 510(k) submission K073408 with a decision of substantially equivalent (SESE) on December 19, 2007, under product code IYN.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073408 | Date19 Dec 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
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Questions
What type of imaging does the GE LOGIQ BT08 system provide?
The device is described as a full‑feature, general purpose diagnostic ultrasound system, which means it is intended for ultrasound imaging across a range of clinical applications. This conclusion follows directly from the description stating it is a diagnostic ultrasound system.
How is the GE LOGIQ BT08 supplied and what are its main hardware components?
According to the data, the system is supplied as a mobile console unit that includes a computer keyboard, specialized controls, a 10‑inch LCD touch screen, and a 19‑inch color LCD image display. The description of the console’s dimensions (approximately 58 cm deep and 141 cm high) confirms these components are integrated into a single mobile platform.
Is the GE LOGIQ BT08 intended for single‑use or reusable applications?
The information provided does not mention disposables, single‑use labeling, or any limitation to one‑time use. As a diagnostic ultrasound console, it is a reusable piece of equipment that remains in the clinical setting for repeated examinations.
What regulatory pathway was used for the GE LOGIQ BT08 and what does that imply about its clearance?
The device was cleared via an FDA 510(k) submission (K073408) with a decision of substantially equivalent (SESE) on December 19, 2007. This indicates the manufacturer demonstrated that the system is substantially equivalent to a legally marketed predicate device, satisfying the requirements of the 510(k) pathway.
What are the physical dimensions of the console and how might that affect placement in a clinic?
The console is approximately 58 cm deep and 141 cm high, which suggests it occupies a moderate footprint and can be positioned on a standard exam room floor or a mobile cart. These dimensions help clinicians plan for space allocation and mobility within the clinical environment.