510(k) Report

FDA applicant

R4 Telemedicine, Inc.

Washington, DC1 decision2000–20000 recalls

FDA records 1 decision for R4 Telemedicine, Inc. (Washington, DC) in 2000: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). 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 R4 Telemedicine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for R4 Telemedicine, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — R4 Telemedicine, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like R4 Telemedicine, 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

Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K000443Remote Fetal Medicine Ultrasound SystemR4 Telemedicine, Inc. · 20002cite it

What has FDA decided for it lately?

  • K000443Remote Fetal Medicine Ultrasound SystemR4 Telemedicine, Inc. · 2000

The one decision as R4 Telemedicine, Inc. →