AS Software

Primary DI
00860010575321
Brand
AS Software
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

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260205000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260205000AS Software Version AseraAS Software, LLC2026-02-19LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010575321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010575321008600105753218600105753210860010575321

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system application softwareAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
046538748
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010575314AS SoftwareAS Online2026-03-10
00860010575307AS-EMR SYSTEM; AS-OBGYN INFORMATION SYSTEM102023-07-13

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