510(k) Report

FDA applicant

Nova Therapeutic System

South Pasadena, CA1 decision1996–19960 recalls

FDA records 1 decision for Nova Therapeutic System (South Pasadena, CA) in 1996: 1 510(k) clearance. All are in product code IWB (System, Radiation Therapy, Radionuclide). 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 Nova Therapeutic System’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nova Therapeutic System since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nova Therapeutic System 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?

  • IWBSystem, Radiation Therapy, Radionuclide1decision

What has FDA decided for it lately?

  • K960892The Cobalt ScalpelNova Therapeutic System · 1996

The one decision as Nova Therapeutic System →

Other applicant names beginning “Nova”

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

Nova Biomedical Corp. 129Nova-Ventrx 12Nova Medical Specialties 11Nova Technology Corp. 3Nova Health Systems, Inc. 3Nova Medical, Inc. 1Nova Corp. 1Nova Technologies, Inc. 1Nova/Da Vinci Systems, Inc. 1Nova Design Technologies, Ltd. 1Nova Ranger, Inc. 1Nova Rubber Glove Industries Sdn. Bhd. 1