510(k) Report

FDA applicant

Rosses Medical Systems

Jessup, MD1 decision1998–19980 recalls

FDA records 1 decision for Rosses Medical Systems (Jessup, MD) in 1998: 1 510(k) clearance. All are in product code MUJ (System, Planning, Radiation Therapy Treatment). 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 Rosses Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rosses Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MUJSystem, Planning, Radiation Therapy Treatment1decision

What has FDA decided for it lately?

  • K981678Strata, Model V.O.95Rosses Medical Systems · 1998

The one decision as Rosses Medical Systems →