AS Software
- Primary DI
- 00860010575321
- Company
- As Software, LLC
- Model
- Asera
- Device description
- AS Software Version Asera 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. Asera 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.
- Published
- 2026-03-10
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Regulatory Flags
- DUNS number
- 046538748
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00860010575321 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00860010575321 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| LLZ | System, Image Processing, Radiological | 2 | Radiology | 892.2050 | N | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K260205 | 000 | AS Software Version Asera | AS Software, LLC | 2026-02-19 | LLZ |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Device Sizes
No records found.
Storage And Handling
No records found.
Contacts
No records found.
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00860010575314 | AS Software | AS Online | | 2026-03-10 |
| 00860010575307 | AS-EMR SYSTEM; AS-OBGYN INFORMATION SYSTEM | 10 | | 2023-07-13 |
Other Devices Sharing Product Codes