GE Logiq 5 Pro or Expert
510(k) K032974
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032974 | Date21 Oct 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- Withdrawn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
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The GE LOGIQ 5 PRO OR EXPERT is a medical imaging device classified as a color Doppler ultrasound system. It is designed to provide high-quality diagnostic imaging for various clinical applications, including radiology, vascular, breast, interventional, musculoskeletal, cardiac, and OB/GYN procedures.
The device is supplied as a reusable system and is intended for use in clinical settings. It is not specified as single-use. The device is not described as MRI-safe. Storage and size specifications are not provided in the data. The device is authorized by the FDA under a 510(k) clearance, classified as substantially equivalent to predicate devices.
Other devices from General Electric Co.
Questions
AI-generated answers, 26 Sep 2026
What is the GE LOGIQ 5 PRO OR EXPERT used for?
It is a color Doppler ultrasound system designed for high-quality diagnostic imaging across multiple clinical applications, including radiology, vascular, breast, interventional, musculoskeletal, cardiac, and OB/GYN procedures.
Is the GE LOGIQ 5 PRO OR EXPERT a single-use device?
No, the device is supplied as a reusable system intended for use in clinical settings.
How is the GE LOGIQ 5 PRO OR EXPERT authorized for use?
The device is authorized by the FDA under a 510(k) clearance, classified as substantially equivalent to predicate devices.