510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

As Software, LLC

Englewood Cliffs, NJ, US

AS SOFTWARE, LLC appears in FDA device records in Englewood Cliffs, NJ. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for As Software, LLC between 2005 and 2026. The busiest year on record is 2005, with 1. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for As Software, LLC, by decision year
YearClearances
20051
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260205AS Software Version AseraLLZSubstantially Equivalent
K051639AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEMLLZSubstantially Equivalent

Registered establishments

FDA registered establishments for As Software, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30052070943005207094AS SOFTWARE, LLC560 Sylvan Ave, Englewood Cliffs, NJ 07632 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0118-2019AS-OBGYN Information System version 7.824.xAny 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 systemClass IITerminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets As Software, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain