FDA UDI
In Commercial Distribution
🇺🇸 United States
Caption
DI: 00198953030233
·
Model: AI
·
GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Caption
- Primary DI
- 00198953030233
- Version / Model
- AI
- Company Name
- GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC
- Labeler DUNS
- 119309548
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-28
- Public Version
- 2
- Public Version Date
- 2026-02-18
- Public Version Status
- Update
- Public Device Record Key
- a5c26931-6ec5-4eb7-b20c-ec676aea1478
Device Description
Caption AI on Vscan
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | Radiology | 892.2050 | 2 |
| QJU | Image Acquisition And/Or Optimization Guided By Artificial Intelligence | Radiology | 892.2100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40873 | Ultrasound imaging system application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00198953030233 | GS1 |