FDA UDI
In Commercial Distribution
🇺🇸 United States
AS Software
DI: 00860010575314
·
Model: AS Online
·
As Software, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AS Software
- Primary DI
- 00860010575314
- Version / Model
- AS Online
- Company Name
- As Software, LLC
- Labeler DUNS
- 046538748
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-10
- Public Version
- 1
- Public Version Date
- 2026-03-18
- Public Version Status
- New
- Public Device Record Key
- 3e0641c5-a507-473f-8f20-d137a229c428
Device Description
AS Online is an ultrasound reporting and management system that allows for the management of patient information and is intended to automate and enhance the processes by which ultrasound examination information is captured, reported, stored, and retrieved by medical providers. AS Online provides the ability for sonographers, obstetricians, gynecologists, perinatologists, radiologists, and cardiologists to capture examination data and images from ultrasound machines in DICOM format and to generate electronic and printed medical records from them. The system is able to be configured depending on specific requirements.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 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 | 00860010575314 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051639 | 000 |