FDA applicant

Radiology Information Systems, Inc.

Vienna, VA3 decisions1997–20190 recalls

FDA records 3 decisions for Radiology Information Systems, Inc. (Vienna, VA) from 1997 to 2019: 3 510(k) clearances. Most are in product codes LMD (System, Digital Image Communications…) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Radiology Information Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Radiology Information Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Radiology Information Systems, Inc.’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

Other applicant names beginning “Radiology”

FDA records each applicant name separately; these may or may not be the same firm.

Radiology Solutions, LLC 2 Radiology Support Devices, Inc. 1 Radiology Design 1 Radiology Telenetwork Intl. 1

Radiology Information Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Radiology”