FDA UDI
In Commercial Distribution
🇺🇸 United States
Sonio Suspect
DI: 03770024341034
·
Model: 1
·
SONIO
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sonio Suspect
- Primary DI
- 03770024341034
- Version / Model
- 1
- Company Name
- SONIO
- Labeler DUNS
- 274345745
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-03
- Public Version
- 1
- Public Version Date
- 2025-09-11
- Public Version Status
- New
- Public Device Record Key
- f691bb75-fbcd-4caf-a620-86206e0db065
Device Description
Sonio Suspect is intended to assist interpreting physicians, during or after fetal ultrasound examinations, by automatically identifying and characterizing abnormal fetal ultrasound findings on detected views, using machine learning techniques. The device is intended for use as a concurrent reading aid on acquired images, during and/or after fetal ultrasound examinations. The device provides information on abnormal findings that may be useful in rendering potential diagnosis. Patient management decisions should not be made solely on the results of the Sonio Suspect analysis.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | Radiology | 892.2060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40762 | Obstetrical/gynaecological ultrasound imaging system | An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) obstetrical and gynaecological (OB/GYN) imaging procedures. It includes software packages to support a variety of static and real-time OB/GYN imaging applications involving foetal imaging, amniocentesis procedures and uterine imaging. The system generates ultrasound pulses, directs them to the target area, detects the ultrasound echoes, and processes the resulting information to produce and display static or dynamic two- or three-dimensional (3-D) images of human anatomy. It is also used to guide and confirm placement of other medical instruments in use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03770024341034 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243614 | 000 |