510(k) Report

FDA applicant

Ssgi Prowess Systems

Chico, CA2 decisions1998–19980 recalls

FDA records 2 decisions for Ssgi Prowess Systems (Chico, CA) in 1998: 2 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and IYE (Accelerator, Linear, Medical). Its devices cite 5 predicates, 1 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 Ssgi Prowess Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ssgi Prowess Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ssgi Prowess 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
  • IYEAccelerator, Linear, Medical1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K980379Prowess Pro-SimSsgi Prowess Systems · 19983cite it

What has FDA decided for it lately?

  • K984196Modification to Prowess Pro-SimSsgi Prowess Systems · 1998
  • K980379Prowess Pro-SimSsgi Prowess Systems · 1998

All 2 as Ssgi Prowess Systems →