510(k) Report

FDA applicant

Segami Corporation

Columbia, MD6 decisions1997–20070 recalls

FDA records 6 decisions for Segami Corporation (Columbia, MD) from 1997 to 2007: 6 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and KPS (System, Tomography, Computed, Emission). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Segami Corp., Inc.”.

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 Segami Corporation’s devices, and how often a recall has named them.

FDA decisions per year

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Segami Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological5decisions
  • KPSSystem, Tomography, Computed, Emission1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 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.

  • K043441Mirage, Release 5.5Segami Corporation · 20054cite it
  • K010726Modification to MirageSegami Corp., Inc. · 20014cite it
  • K972886MirageSegami Corp., Inc. · 19974cite it
  • K070397Dgscope, Release 1.0Segami Corporation · 20071cites it
  • K071584Oasis Release 1.0Segami Corporation · 20071cites it

What has FDA decided for it lately?

  • K071584Oasis Release 1.0Segami Corporation · 2007
  • K070397Dgscope, Release 1.0Segami Corporation · 2007
  • K070683Mirage Cedars OptionSegami Corporation · 2007
  • K043441Mirage, Release 5.5Segami Corporation · 2005
  • K010726Modification to MirageSegami Corp., Inc. · 2001
  • K972886MirageSegami Corp., Inc. · 1997

All 4 as Segami Corporation →All 2 as Segami Corp., Inc. →