510(k) Report

FDA applicant

Cmsi

Mchenry, IL3 decisions1979–19890 recalls

FDA records 3 decisions for Cmsi (Mchenry, IL) from 1979 to 1989: 3 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and EQJ (Bur, Ear, Nose And Throat). 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 Cmsi’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cmsi since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cmsi’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?

  • KPSSystem, Tomography, Computed, Emission1decision
  • EQJBur, Ear, Nose And Throat1decision
  • KQADevice, Beam Limiting, X-Ray, Therapeutic1decision

What has FDA decided for it lately?

  • K893499CMS Fast Cut, CMS Diamond and CMS Wire PassCmsi · 1989
  • K790169Tomographic ProgramsCmsi · 1979
  • K790168Collimator, BilaterialCmsi · 1979

All 3 as Cmsi →