Data / Medical devices / United States / AS Software, LLC
AS Software, LLC: FDA-registered device maker in Englewood Cliffs, NJ, United States, 2 510(k) clearances
AS Software, LLC is registered with the FDA (registration 3005207094) in Englewood Cliffs, NJ, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 19, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005207094
- Address
- 560 Sylvan Ave, Englewood Cliffs, NJ, United States, 07632
- Owner or operator
- AS SOFTWARE (9074082)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 24, 2007
- Registered through
- 2026
- Brand names listed
- AS Asera, AS Online, AS-EMR SYSTEM, AS-OBGYN INFORMATION SYSTEM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 19, 2026 | K260205 | AS Software Version Asera | LLZ | Substantially Equivalent | AS Software, LLC | accessdata.fda.gov |
| August 2, 2005 | K051639 | AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM | LLZ | Substantially Equivalent | As Software, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 20, 2018 | 81057 | Class II | Terminated | AS-OBGYN Information System version 7.824.x | Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that ultrasound measurements are crossing over correctly to the AS system | accessdata.fda.gov |
Compare with other makers
Updated February 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.