Sonoreal 3D System
by Bio Medi Com
510(k) K020068
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020068 | Date4 Mar 2002 | 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- Withdrawn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
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Sonoreal 3D System is an accessory designed for use with standard 2D ultrasound systems. It functions by capturing 2D ultrasound video signals to provide 3D and multi-planar clinical imaging capabilities.
This device is intended to be used by or under the direction of a physician for fetal and gynecological applications. It has received FDA 510(k) clearance under the reference number K020068.
Other devices from Bio Medi Com
Questions
AI-generated answers, 22 Sep 2026
What is the primary function of the Sonoreal 3D System?
The Sonoreal 3D System acts as an accessory for standard 2D ultrasound equipment. It captures incoming 2D video signals and processes them to generate 3D and multi-planar clinical imaging, which assists physicians in visualizing diagnostic data.
Which clinical applications is this system intended for?
This device is specifically intended for use in fetal and gynecological applications. It must be operated by or under the direct supervision of a physician to ensure appropriate clinical use.
What is the regulatory status of the Sonoreal 3D System?
The Sonoreal 3D System has received FDA 510(k) clearance under the reference number K020068. This indicates that the device was reviewed and determined to be substantially equivalent to existing legally marketed devices.