FDA applicant
AS Software, LLC
FDA records 2 decisions for AS Software, LLC (Englewood Cliffs, NJ) from 2005 to 2026: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 4 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “As Software, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided AS Software, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like AS Software, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report